AzTrials
AzTrials

Hepatitis C, ChronicPhase 4NCT01675427

A Study on the Correlation Between Interleukin 28B Genotypes With Clinical and Demographic Characteristics in Treatment-Naïve and Treatment-Experienced Patients With Chronic Hepatitis C

A Phase 4 study testing Interleukin 28B testing in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 210 sites in 31 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This multicenter study will evaluate the correlation of interleukin 28B (IL28B) genotypes with disease characteristics and demographics in treatment-naïve and treatment-experienced chronic hepatitis C patients, including patients with HIV co-infection. There will be a single study visit for testing. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
Interleukin 28B testing
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,766 participants
Where
210 sitesin 31 countries
Study dates
Aug 2011to Oct 2013
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Adult (according to local legislation) male or female patient
  • Chronic hepatitis C (CHC)
  • Patients naïve to CHC treatment or patients who received prior interferon-based therapy for CHC for whom data on treatment received and treatment outcome is available; information on fibrosis stage prior to previous treatment is also required

Who cannot join

  • Co-infection with hepatitis B
  • History or evidence of decompensated liver disease
  • History of major organ transplantation with an existing functional graft (including liver transplantation)
  • End stage renal disease

Trial locations and contacts

210 sites in 31 countries.

210 sites in 31 countries

Italy47 sites
  • Study site

    Arezzo, Tuscany, 52100

  • Study site

    Avellino, Campania, 83100

  • Study site

    Bari, Apulia, 70124

  • Study site

    Biella, Piedmont, 13900

  • Study site

    Bisceglie, Apulia, 70052

  • Study site

    Bologna, Emilia-Romagna, 40138

  • Study site

    Cagliari, Sardinia, 09042

  • Study site

    Cagliari, Sardinia, 09100

  • Study site

    Castellana Grotte, Apulia, 70013

  • Study site

    Catania, Sicily, 95100

  • Study site

    Catania, Sicily, 95126

  • Study site

    Chieti, Abruzzo, 66013

  • Study site

    Cuorgnè (TO), Piedmont, 10082

  • Study site

    Florence, Tuscany, 50134

  • Study site

    Genoa, Liguria, 16132

  • Study site

    Gragnano, Campania, 80054

  • Study site

    Livorno, Tuscany, 57124

  • Study site

    Marcianise, Campania, 81025

  • Study site

    Messina, Sicily, 98124

  • Study site

    Milan, Lombardy, 20122

  • Study site

    Milan, Lombardy, 20123

  • Study site

    Milan, Lombardy, 20132

  • Study site

    Milan, Lombardy, 20142

  • Study site

    Milan, Lombardy, 20157

  • Study site

    Milan, Lombardy, 20162

  • Study site

    Modena, Emilia-Romagna, 41100

  • Study site

    Naples, Campania, 80131

  • Study site

    Naples, Campania, 80136

  • Study site

    Naples, Campania, 80138

  • Study site

    Nocera Inferiore, Campania, 84014

  • Study site

    Nola, Campania, 80035

  • Study site

    Omegna (VB), Piedmont, 28887

  • Study site

    Padova, Veneto, 35128

  • Study site

    Palermo, Sicily, 90127

  • Study site

    Parma, Emilia-Romagna, 43126

  • Study site

    Piacenza, Emilia-Romagna, 29121

  • Study site

    Reggio Calabria, Calabria, 89100

  • Study site

    Rome, Lazio, 00149

  • Study site

    Rome, Lazio, 00152

  • Study site

    Rome, Lazio, 00161

  • Study site

    Rome, Lazio, 00165

  • Study site

    Rome, Lazio, 00189

  • Study site

    San Giovanni Rotondo, Apulia, 71013

  • Study site

    Sassari, Sardinia, 07100

  • Study site

    Savona, Liguria, 17100

  • Study site

    Torrette Di Ancona, The Marches, 60020

  • Study site

    Udine, Friuli Venezia Giulia, 33100

Other trials in Italy

Belgium18 sites
  • Study site

    Antwerp, 2060

  • Study site

    Bruges, 8000

  • Study site

    Brussels, 1000

  • Study site

    Brussels, 1020

  • Study site

    Brussels, 1070

  • Study site

    Brussels, 1090

  • Study site

    Brussels, 1180

  • Study site

    Brussels, 1190

  • Study site

    Edegem, 2650

  • Study site

    Genk, 3600

  • Study site

    Ghent, 9000

  • Study site

    Hasselt, 3500

  • Study site

    Heusy, 4802

  • Study site

    Kortrijk, 8500

  • Study site

    Leuven, 3000

  • Study site

    Liège, 4000

  • Study site

    Ostend, 8400

  • Study site

    Roeselare, 8800

Other trials in Belgium

Turkey (Türkiye)17 sites
  • Study site

    Adana, 01100

  • Study site

    Adapazarı

  • Study site

    Ankara, 06100

  • Study site

    Ankara, 06290

  • Study site

    Ankara, 06800

  • Study site

    Ankara

  • Study site

    Eskişehir, 26480

  • Study site

    Hatay, 31040

  • Study site

    Istanbul, 34390

  • Study site

    ISTANBULt

  • Study site

    Izmir, 35100

  • Study site

    Kayseri, 38039

  • Study site

    Mersin, 33169

  • Study site

    Samsun, 55139

  • Study site

    Tokat Province, 60250

  • Study site

    Trabzon, 61080

  • Study site

    Zonguldak

Other trials in Turkey (Türkiye)

Germany16 sites
  • Study site

    Aachen, 52074

  • Study site

    Berlin, 10243

  • Study site

    Berlin, 10777

  • Study site

    Burghausen, 84489

  • Study site

    Cologne, 50937

  • Study site

    Düsseldorf, 40237

  • Study site

    Erlangen, 91054

  • Study site

    Essen, 45122

  • Study site

    Frankfurt (Oder), 15236

  • Study site

    Kassel, 34117

  • Study site

    Lübeck, 23562

  • Study site

    Magdeburg, 39120

  • Study site

    Mannheim, 68167

  • Study site

    Rostock, 18057

  • Study site

    Rottenburg, 72108

  • Study site

    Tübingen, 72076

Other trials in Germany

France15 sites
  • Study site

    Avignon, 84902

  • Study site

    Châteauroux, 36019

  • Study site

    Créteil, 94010

  • Study site

    Lille, 59037

  • Study site

    Lyon, 69317

  • Study site

    Marseille, 13385

  • Study site

    Nice, 06202

  • Study site

    Paris, 75571

  • Study site

    Paris, 75679

  • Study site

    Pessac, 33604

  • Study site

    Rennes, 35033

  • Study site

    Rouen, 76031

  • Study site

    Strasbourg, 67091

  • Study site

    Toulouse, 31059

  • Study site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Greece9 sites
  • Study site

    Alexandroupoli, 68100

  • Study site

    Athens, 115 27

  • Study site

    Athens, 11522

  • Study site

    Athens, 11527

  • Study site

    Ioannina, 455 00

  • Study site

    Larissa, 41 110

  • Study site

    Nea Kifissia, 14564

  • Study site

    Pátrai, 265 04

  • Study site

    Thessaloniki, 546 42

Other trials in Greece

Portugal8 sites
  • Study site

    Almada, 2805-267

  • Study site

    Amadora, 2700-020

  • Study site

    Aveiro, 3810-096

  • Study site

    Faro, 8000-386

  • Study site

    Lisbon, 1349-019

  • Study site

    Lisbon, 1649-035

  • Study site

    Porto, 4099-001

  • Study site

    Porto, 4202-451

Other trials in Portugal

Romania8 sites
  • Study site

    Bucharest, 021105

  • Study site

    Bucharest, 022328

  • Study site

    Cluj-Napoca, 400162

  • Study site

    Constanța

  • Study site

    Iași, 700554

  • Study site

    Iași, 700620

  • Study site

    Timișoara, 293406

  • Study site

    Timișoara, 300167

Other trials in Romania

Lithuania7 sites
  • Study site

    Kaunas, 47116

  • Study site

    Kaunas, 50009

  • Study site

    Klaipėda, 92288

  • Study site

    Panevezys, 35144

  • Study site

    Šiauliai, 76231

  • Study site

    Vilnius, 08117

  • Study site

    Vilnius, 08661

Other trials in Lithuania

Lebanon6 sites
  • Study site

    Baabda, 50

  • Study site

    Beirut, 11-236

  • Study site

    Beirut, 99999

  • Study site

    Beirut

  • Study site

    Nabatieh

  • Study site

    Tripoli, 371 Tripoli

Other trials in Lebanon

Pakistan6 sites
  • Study site

    Faisalabad

  • Study site

    Gujranwala

  • Study site

    Karachi

  • Study site

    Lahore, 20021

  • Study site

    Lahore

  • Study site

    Rawalpindi

Other trials in Pakistan

Slovakia6 sites
  • Study site

    Banská Bystrica, 975 17

  • Study site

    Bratislava, 811 07

  • Study site

    Bratislava, 833 03

  • Study site

    Bratislava, 833 05

  • Study site

    Martin, 036 59

  • Study site

    Prešov, 080 01

Other trials in Slovakia

Taiwan6 sites
  • Study site

    Kaohsiung City, 00833

  • Study site

    Kaohsiung City, 807

  • Study site

    Taichung, 40447

  • Study site

    Taipei, 100

  • Study site

    Taipei, 112

  • Study site

    Taoyuan, 333

Other trials in Taiwan

Egypt5 sites
  • Study site

    Cairo, 11559

  • Study site

    Cairo

  • Study site

    Giza

  • Study site

    Menoufiya, 32511

  • Study site

    Tanta

Other trials in Egypt

Estonia5 sites
  • Study site

    Kohtla-Järve, 31025

  • Study site

    Pärnu, 80010

  • Study site

    Tallinn, 10138

  • Study site

    Tallinn, 10617

  • Study site

    Tartu, 51014

Other trials in Estonia

Venezuela5 sites
  • Study site

    Caracas, 1010

  • Study site

    Caracas, 1060

  • Study site

    Caracas, 1073

  • Study site

    Caracas, 1080

  • Study site

    Maracaibo, 4005

Other trials in Venezuela

Mexico4 sites
  • Study site

    Culiacán, 80220

  • Study site

    Mexico City, 02990

  • Study site

    Mexico City, 14050

  • Study site

    Tijuana, 22450

Other trials in Mexico

Sweden3 sites
  • Study site

    Gävle, 80187

  • Study site

    Karlstad, 65185

  • Study site

    Uppsala, 75185

Other trials in Sweden

Argentina2 sites
  • Study site

    Buenos Aires, CP B1704 ETD

  • Study site

    Mar del Plata, 7600

Other trials in Argentina

Chile2 sites
  • Study site

    Santiago, 8330024

  • Study site

    Santiago, 8380456

Other trials in Chile

Peru2 sites
  • Study site

    La Victoria, Lima, Lima 13

  • Study site

    Lima, 11

Other trials in Peru

Serbia2 sites
  • Study site

    Belgrade, 11000

  • Study site

    Novi Sad, 21000

Other trials in Serbia

Switzerland2 sites
  • Study site

    Lugano, 6900

  • Study site

    Sankt Gallen, 9007

Other trials in Switzerland

United Arab Emirates2 sites
  • Study site

    Dubai, 4545

  • Study site

    Sharjah city, P.O.Box: 5735 - Sharjah, UAE

Other trials in United Arab Emirates

United States1 site
  • Study site

    Alexandria, Virginia, 22304

Other trials in United States

Kuwait1 site
  • Study site

    Safat, 4077

Other trials in Kuwait

Latvia1 site
  • Study site

    Riga, 1006

Other trials in Latvia

North Macedonia1 site
  • Study site

    Skopje, 1000

Other trials in North Macedonia

Oman1 site
  • Study site

    Muscat, P.O Box 35

Other trials in Oman

Qatar1 site
  • Study site

    Doha, P.O.Box 3051

Other trials in Qatar

Syria1 site
  • Study site

    Aleppo, 6448

Other trials in Syria

About this study

Official title: An International, Multi-Center Study Evaluating the Correlation of IL28B Genotypes With Patient Demographics and Disease Characteristics in Patients With Chronic Hepatitis C

This multicenter study will evaluate the correlation of interleukin 28B (IL28B) genotypes with disease characteristics and demographics in treatment-naïve and treatment-experienced chronic hepatitis C patients, including patients with HIV co-infection. There will be a single study visit for testing.

Being tested
Interleukin 28B testing
Medical subject headings
Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interleukin 28B testingOther

    Blood sampling for ILB28 genotyping

Study groups in NCT01675427
Study groupRoleWhat they receive
Chronic hepatitis C patientsExperimentalNot described
Receives: Other: Interleukin 28B testing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With Interleukin 28B (IL28B) Genotype rs12979860 by Cirrhosis Status and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype (Genotype 1 [G1], Genotype 2 [G2], Genotype 3 [G3], Genotype 4 [G4], and all other genotypes [Other]) and cirrhosis status ('Cirrhosis/transition to cirrhosis' or 'No cirrhosis') were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.

    Measured: Study Visit 1 (single study visit)

  2. Number of Participants With IL28B Genotype rs12979860 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.

    Measured: Study Visit 1

  3. Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.

    Measured: Study Visit 1

  4. Number of Participants With IL28B Genotype rs8099917 by Cirrhosis Status and HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and cirrhosis status were obtained from medical records. Cirrhosis status was based upon previous biopsy or noninvasive assessment captured prior to treatment, if applicable.

    Measured: Study Visit 1

  5. Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.

    Measured: Study Visit 1

  6. Number of Participants With IL28B Genotype rs12979860 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.

    Measured: Study Visit 1

  7. Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.

    Measured: Study Visit 1

  8. Number of Participants With IL28B Genotype rs8099917 by Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage ('Cirrhotic,' 'Transition to cirrhosis,' 'Advanced fibrosis noncirrhotic,' 'Mild/minimal fibrosis,' and 'No fibrosis') were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using these five categories and captured prior to treatment, if applicable.

    Measured: Study Visit 1

  9. Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.

    Measured: Study Visit 1

  10. Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.

    Measured: Study Visit 1

  11. Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.

    Measured: Study Visit 1

  12. Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Fibrosis Stage and HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver fibrosis stage (Stage F0, Stage F1, Stage F2, Stage F3, or Stage F4) were obtained from medical records. Liver fibrosis stage was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.

    Measured: Study Visit 1

  13. Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kilopascals (kPa).

    Measured: Study Visit 1

  14. Mean FibroScan Values by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.

    Measured: Study Visit 1

  15. Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.

    Measured: Study Visit 1

  16. Mean FibroScan Values by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver elastography (FibroScan) were obtained from medical records. FibroScan values were based upon previous noninvasive assessment captured prior to treatment, if applicable. Mean FibroScan values were determined by averaging the values of all participants within each arm and expressed in kPa.

    Measured: Study Visit 1

Secondary outcomes (78)
  1. Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.

    Measured: Study Visit 1

  2. Number of Participants With IL28B Genotype rs12979860 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.

    Measured: Study Visit 1

  3. Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.

    Measured: Study Visit 1

  4. Number of Participants With IL28B Genotype rs8099917 by METAVIR Liver Inflammation Grade and HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and liver inflammation grade (Grade A0, Grade A1, Grade A2, or Grade A3) were obtained from medical records. Liver inflammation grade was based upon previous biopsy using the METAVIR scoring system and captured prior to treatment, if applicable.

    Measured: Study Visit 1

  5. Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.

    Measured: Study Visit 1

  6. Number of Participants With IL28B Genotype rs12979860 by Gender: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.

    Measured: Study Visit 1

  7. Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.

    Measured: Study Visit 1

  8. Number of Participants With IL28B Genotype rs8099917 by Gender: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including gender, were obtained from medical records and/or participant interview at the Study Visit.

    Measured: Study Visit 1

  9. Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.

    Measured: Study Visit 1

  10. Number of Participants With IL28B Genotype rs12979860 by Ethnic Origin: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.

    Measured: Study Visit 1

  11. Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.

    Measured: Study Visit 1

  12. Number of Participants With IL28B Genotype rs8099917 by Ethnic Origin: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including self-reported ethnic origin, were obtained from medical records and/or participant interview at the Study Visit.

    Measured: Study Visit 1

  13. Mean Body Weight by IL28B Genotype rs12979860: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kilograms (kg).

    Measured: Study Visit 1

  14. Mean Body Weight by IL28B Genotype rs12979860: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.

    Measured: Study Visit 1

  15. Mean Body Weight by IL28B Genotype rs8099917: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.

    Measured: Study Visit 1

  16. Mean Body Weight by IL28B Genotype rs8099917: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Mean body weight was calculated by averaging the values of all participants within each arm and expressed in kg.

    Measured: Study Visit 1

  17. Mean Body Mass Index (BMI) by IL28B Genotype rs12979860: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kilograms per meter-squared (kg/m^2), and mean BMI was calculated by averaging the values of all participants within each arm.

    Measured: Study Visit 1

  18. BMI by IL28B Genotype rs12979860: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.

    Measured: Study Visit 1

  19. BMI by IL28B Genotype rs8099917: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.

    Measured: Study Visit 1

  20. BMI by IL28B Genotype rs8099917: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Demographic characteristics, including height and pre-treatment body weight, were obtained from medical records and/or participant interview at the Study Visit. Each participant's BMI was calculated as weight divided by height-squared, expressed in kg/m^2, and mean BMI was calculated by averaging the values of all participants within each arm.

    Measured: Study Visit 1

  21. Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.

    Measured: Study Visit 1

  22. Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.

    Measured: Study Visit 1

  23. Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.

    Measured: Study Visit 1

  24. Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records.

    Measured: Study Visit 1

  25. Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 international units per milliliter (log10 IU/mL).

    Measured: Study Visit 1

  26. Mean HCV RNA Level by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.

    Measured: Study Visit 1

  27. Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.

    Measured: Study Visit 1

  28. Mean HCV RNA Level by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA level was obtained from medical records. Mean HCV RNA level was calculated by averaging the values of all participants within each arm and expressed in log10 IU/mL.

    Measured: Study Visit 1

  29. Mean Alanine Aminotransferase (ALT) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 international units per liter [IU/L] for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.

    Measured: Study Visit 1

  30. Mean ALT Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 IU/L for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.

    Measured: Study Visit 1

  31. Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 IU/L for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.

    Measured: Study Visit 1

  32. Mean ALT Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. ALT level was obtained from medical records captured prior to treatment, if applicable. Each participant's ALT ratio was calculated as ALT level divided by the upper limit of normal (55 IU/L for males and 30 IU/L for females). Mean ALT ratio was calculated by averaging the values of all participants within each arm.

    Measured: Study Visit 1

  33. Mean Aspartate Aminotransferase (AST) Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.

    Measured: Study Visit 1

  34. Mean AST Ratio by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.

    Measured: Study Visit 1

  35. Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.

    Measured: Study Visit 1

  36. Mean AST Ratio by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. AST level was obtained from medical records captured prior to treatment, if applicable. Each participant's AST ratio was calculated as AST level divided by the upper limit of normal (40 IU/L for males and 25 IU/L for females). Mean AST ratio was calculated by averaging the values of all participants within each arm.

    Measured: Study Visit 1

  37. Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells per liter (10^9 cells/L).

    Measured: Study Visit 1

  38. Mean Platelet Count by IL28B Genotype rs12979860 and HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.

    Measured: Study Visit 1

  39. Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.

    Measured: Study Visit 1

  40. Mean Platelet Count by IL28B Genotype rs8099917 and HCV RNA Genotype: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. Platelet count was obtained from medical records captured prior to treatment, if applicable. Mean platelet count was calculated by averaging the values of all participants within each arm and expressed in 10^9 cells/L.

    Measured: Study Visit 1

  41. Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  42. Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Region: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  43. Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  44. Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Region: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  45. Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  46. Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  47. Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  48. Number of Participants With IL28B Genotype rs12979860 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  49. Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  50. Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  51. Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  52. Number of Participants With IL28B Genotype rs8099917 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  53. Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype.

    Measured: Study Visit 1

  54. Number of Participants With IL28B Genotype rs12979860 by IL28B Genotype rs8099917 Category: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype.

    Measured: Study Visit 1

  55. Number of Participants With Inosine Triphosphatase (ITPA) Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine ITPA genotype.

    Measured: Study Visit 1

  56. Number of Participants With ITPA Genotype rs7270101 by ITPA Genotype rs1127354 Category: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine ITPA genotype.

    Measured: Study Visit 1

  57. Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  58. Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Region: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  59. Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Naive

    Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  60. Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Region: Treatment-Experienced

    Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and geographic region of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  61. Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])

    Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  62. Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])

    Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  63. Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])

    Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  64. Number of Participants With ITPA Genotype rs1127354 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])

    Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  65. Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 1 of 2 [G1, G2, G3])

    Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  66. Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Naive (Table 2 of 2 [G4, Other, Total])

    Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  67. Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 1 of 2 [G1, G2, G3])

    Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  68. Number of Participants With ITPA Genotype rs7270101 by HCV RNA Genotype and Country: Treatment-Experienced (Table 2 of 2 [G4, Other, Total])

    Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records, and country of study site was documented during intake/enrollment.

    Measured: Study Visit 1

  69. Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types within the first 12 weeks of treatment included rapid virological response (RVR), complete early virological response (cEVR), and partial early virological response (pEVR). RVR was defined as an undetectable HCV RNA level within the first 4 weeks, cEVR as an undetectable level within the first 12 weeks, and pEVR as a 2-log drop from Baseline to 12 weeks. Undetectable viral loads include those below the lower limit of detection (LLOD) for the assay performed, which may vary from site to site. Response categories were mutually exclusive, meaning participants could only achieve cEVR/pEVR in the absence of RVR. Participants achieving neither RVR nor cEVR/pEVR were recorded as 'none of the above.'

    Measured: Study Visit 1

  70. Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response in the First 12 Weeks of Treatment and HCV RNA Genotype

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types within the first 12 weeks of treatment included RVR, cEVR, and pEVR. RVR was defined as an undetectable HCV RNA level within the first 4 weeks, cEVR as an undetectable level within the first 12 weeks, and pEVR as a 2-log drop from Baseline to 12 weeks. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site. Response categories were mutually exclusive, meaning participants could only achieve cEVR/pEVR in the absence of RVR. Participants achieving neither RVR nor cEVR/pEVR were recorded as 'none of the above.'

    Measured: Study Visit 1

  71. Number of Participants With IL28B Genotype rs12979860 by Type of Virological Response at End of Treatment and HCV RNA Genotype

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types at the end of treatment included undetectable and detectable HCV RNA level. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site.

    Measured: Study Visit 1

  72. Number of Participants With IL28B Genotype rs8099917 by Type of Virological Response at End of Treatment and HCV RNA Genotype

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Virological response types at the end of treatment included undetectable and detectable HCV RNA level. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site.

    Measured: Study Visit 1

  73. Number of Participants With IL28B Genotype rs12979860 by Overall Virological Response Type and HCV RNA Genotype

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Overall virological response types included sustained virological response (SVR), relapse, and breakthrough. SVR was defined as undetectable HCV RNA level at 24 weeks post-treatment, relapse as an undetectable level at end of treatment with a detectable level at the last post-treatment measurement, and breakthrough as an undetectable level at 1 or more treatment measurements with a detectable level at end of treatment. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site. Response categories were mutually exclusive. Participants with detectable HCV RNA level at 12 or more treatment measurements and who did not meet SVR criteria were considered nonresponders, and those with insufficient treatment response data were recorded as 'none of the above.'

    Measured: Study Visit 1

  74. Number of Participants With IL28B Genotype rs8099917 by Overall Virological Response Type and HCV RNA Genotype

    Participants underwent blood sampling at the Study Visit to determine IL28B genotype. HCV RNA genotype and virological response to prior treatment were obtained from medical records. Overall virological response types included SVR, relapse, and breakthrough. SVR was defined as undetectable HCV RNA level at 24 weeks post-treatment, relapse as an undetectable level at end of treatment with a detectable level at the last post-treatment measurement, and breakthrough as an undetectable level at 1 or more treatment measurements with a detectable level at end of treatment. Undetectable viral loads include those below the LLOD for the assay performed, which may vary from site to site. Response categories were mutually exclusive. Participants with detectable HCV RNA level at 12 or more treatment measurements and who did not meet SVR criteria were considered nonresponders, and those with insufficient treatment response data were recorded as 'none of the above.'

    Measured: Study Visit 1

  75. Number of Participants With ITPA Genotype rs1127354 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype

    Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype and hematology data were obtained from medical records. Participants with a history of a hemoglobin level less than 10 grams per deciliter (g/dL) or a drop of more than 3 g/dL at any time during prior treatment for CHC were recorded as 'yes' for this finding.

    Measured: Study Visit 1

  76. Number of Participants With ITPA Genotype rs7270101 by Incidence of Hemoglobin Drop During Prior Treatment and HCV RNA Genotype

    Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype and hematology data were obtained from medical records. Participants with a history of a hemoglobin level less than 10 g/dL or a drop of more than 3 g/dL at any time during prior treatment for CHC were recorded as 'yes' for this finding.

    Measured: Study Visit 1

  77. Number of Participants With ITPA Genotype rs1127354 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype

    Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records. Past medication use was obtained from medical records and/or participant interview at the Study Visit. Participants with a history of erythropoietin use during prior treatment for CHC were recorded as 'yes' for this finding.

    Measured: Study Visit 1

  78. Number of Participants With ITPA Genotype rs7270101 by Erythropoietin Use During Prior Treatment and HCV RNA Genotype

    Participants underwent blood sampling at the Study Visit to determine ITPA genotype. HCV RNA genotype was obtained from medical records. Past medication use was obtained from medical records and/or participant interview at the Study Visit. Participants with a history of erythropoietin use during prior treatment for CHC were recorded as 'yes' for this finding.

    Measured: Study Visit 1

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2012 (estimated)
  2. Study startAug 2011
  3. Primary completionOct 2013
  4. Study completionOct 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
4,766 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01675427
Sponsor's protocol ID
MV25600
Status last verified
Aug 2015
First submitted
24 Aug 2012
Last updated
26 Aug 2015

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Interleukin 28B testing in people with Hepatitis C, Chronic, run by Hoffmann-La Roche at 210 sites in 31 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Aug 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 210 sites in Italy, Belgium, Turkey (Türkiye), Germany, France and 26 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Interleukin 28B (IL28B) Genotype rs12979860 by Cirrhosis Status and Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Genotype: Treatment-Naive (time frame: Study Visit 1 (single study visit)). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2015.

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