AzTrials
AzTrials

Chronic Hepatitis C Virus (HCV) Infection Genotype 1Phase 3TOPAZ-INCT02219490

A Study to Evaluate Long-term Outcomes Following Treatment With ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

A Phase 3 study testing ABT-450/r/ABT-267, ABT-333 and Ribavirin (RBV) in people with Chronic Hepatitis C Virus (HCV) Infection Genotype 1, run by AbbVie at 187 sites in 27 countries.

Completed

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

Official record
Search all trials

Trial summary

The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
ABT-450/r/ABT-267, ABT-333 and Ribavirin (RBV)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,596 participants
Where
187 sitesin 27 countries
Study dates
30 Oct 2014to 13 May 2021
Phase
Phase 3
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Males and females at least 18 years old at screening
  • Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
  • Chronic hepatitis C, genotype 1 infection
  • Males must be surgically sterile or agree to practice acceptable forms of birth control
  • Screening laboratory result indicating HCV genotype 1 infection

Who cannot join

  • Use of contraindicated medications within 2 weeks of dosing
  • Abnormal laboratory tests
  • Current or past clinical evidence of Child-Pugh B or C classification or history of liver decompensation
  • Confirmed presence of hepatocellular carcinoma
  • History of solid organ transplant

Trial locations and contacts

187 sites in 27 countries.

187 sites in 27 countries

Italy22 sites

  • Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII (Presidio Papa Giovanni /ID# 132188

    Bergamo, 24127

  • Duplicate_A.O.U. Policlinico S.Orsola-Malpighi /ID# 131095

    Bologna, Emilia-Romagna, 40138

  • Azienda Ospedaliero-Universitaria di Ferrara-Arcispedale Sant Anna /ID# 131102

    Cona, Ferrara, 44124

  • Azienda Ospedaliero Universitaria Careggi /ID# 132197

    Florence, 50134

  • Azienda Ospedaliera Universitaria Ospedali Riuniti /ID# 132195

    Foggia, 71122

  • A.O.U. Policlinico G. Martino /ID# 132193

    Messina, 98125

  • Ospedale San Raffaele IRCCS /ID# 131093

    Milan, Lombardy, 20132

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 131097

    Milan, 20122

  • Ospedale S Giuseppe /ID# 132194

    Milan, 20123

  • ASST Santi Paolo e Carlo/Presidio Ospedale San Paolo /ID# 132198

    Milan, 20142

  • ASST Fatebenefratelli Sacco-Ospedale Sacco /ID# 134372

    Milan, 20157

  • Azienda Ospedaliera Niguarda Ca' Granda Hospital /ID# 131104

    Milan, 20162

  • Azienda Ospedaliera Universitaria Federico II /ID# 131096

    Naples, 80131

  • Azienda Ospedaliera Universitaria Federico II /ID# 132191

    Naples, 80131

  • Azienda Ospedaliera Universitaria Paolo Giaccone /ID# 132184

    Palermo, 90127

  • Azienda Ospedaliero-Universitaria di Parma /ID# 132183

    Parma, 43126

  • Policlinico Agostino Gemelli /ID# 131098

    Rome, Lazio, 00168

  • Fondazione PTV Policlinico Tor Vergata /ID# 132185

    Rome, Roma, 00133

  • Azienda Ospedaliera Universitaria "San Giovanni di Dio e Ruggi d'Aragona /ID# 132192

    Salerno, 84131

  • Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 132190

    San Giovanni Rotondo, Foggia, 71013

  • A.O.U. Citta della Salute e della Scienza di Torino /ID# 131100

    Turin, 10126

  • Azienda Ospedaliera Universitaria Friuli Centrale/Presidio Ospedaliero Universit /ID# 132196

    Udine, 33100

Other trials in Italy

Russia16 sites

  • South-Ural State Med. Academy /ID# 132274

    Chelyabinsk, 454052

  • Republican Clinical Infectious Diseases Hospital n.a. Professor A. F. Agafonov /ID# 132270

    Kazan', Tatarstan, Respublika, 420140

  • Kuzbass Center for Prevention and Fight agains AIDS /ID# 132269

    Kemerovo, 650056

  • Krasnoyarsk Regional Center for the Prevention and Control of AIDS /ID# 132278

    Krasnoyarsk, 660049

  • Moscow Clinical Scientific Center n.a. Loginov /ID# 132266

    Moscow, 111123

  • Central Clinical Hospital of Russian Academy of Science /ID# 132289

    Moscow, 117593

  • I. M. Sechenov First Moscow State Medical University /ID# 132275

    Moscow, 119991

  • City Clinical Hospital #24 /ID# 132268

    Moscow, 127015

  • Research Institute of Emergency Medicine named after V.I. N.V. Sklifosovsky /ID# 132288

    Moscow, 129090

  • Clinical Infectious Diseases Hospital #1 /ID# 132272

    Novosibirsk, 630099

  • Medical Company Hepatolog /ID# 132277

    Samara, Samara Oblast, 443063

  • Samara State Medical University /ID# 136913

    Samara, 443099

  • Stavropol State Medical University /ID# 132279

    Stavropol, 355017

  • Tolyatti City Clinical Hospital #1 /ID# 132273

    Tolyatti, 445009

  • Multidisciplinary Consultative and Diagnostic Center /ID# 131130

    Tyumen, 625026

  • Sverdlovsk Regional Clinical Hospital #1 /ID# 132267

    Yekaterinburg, 620102

Other trials in Russia

Canada15 sites

  • University of Calgary /ID# 134370

    Calgary, Alberta, T2N 4Z6

  • GI Research & Associates /ID# 132169

    Edmonton, Alberta, T5H 4B9

  • Clinique Medicale L'Actuel /ID# 132167

    Montreal, Quebec, H2L 4P9

  • Jewish General Hospital /ID# 132165

    Montreal, Quebec, H3T 1E2

  • Royal Victoria Hospital / McGill University Health Centre /ID# 132166

    Montreal, Quebec, H4A 3J1

  • Ottawa Hospital Research Institute /ID# 132170

    Ottawa, Ontario, K1H 8L6

  • CHU de Quebec-Université Laval hôpital CHUL /ID# 132132

    Québec, Quebec, G1V 4G2

  • Saint John Regional Hospital /ID# 131210

    Saint John, New Brunswick, E2L 4L2

  • Toronto General Hospital /ID# 132134

    Toronto, Ontario, M5G 2C4

  • Toronto Liver Centre /ID# 132168

    Toronto, Ontario, M6H 3M1

  • LAIR Centre /ID# 130970

    Vancouver, British Columbia, V5Z 1H3

  • Vancouver Infectious Diseases Centre /ID# 134369

    Vancouver, British Columbia, V6Z 2C7

  • GIRI Gastrointestinal Research Institute /ID# 132171

    Vancouver, British Columbia, V6Z 2K5

  • Toronto Digestive Disease Asso /ID# 130968

    Vaughan, Ontario, L4L 4Y7

  • University of Manitoba / Health Scuience Centre / John Buhler Research Centre /ID# 130969

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

Spain15 sites

  • Hospital Universitario A Coruna - CHUAC /ID# 131137

    A Coruña, 15006

  • Hospital Universitario Germans Trias i Pujol /ID# 132293

    Badalona, Barcelona, 08916

  • OSI Ezkerraldea-Enkarterri-Cruces /ID# 131143

    Barakaldo, Vizcaya, 48903

  • Hospital General Universitario Santa Lucia /ID# 131139

    Cartagena, Murcia, 30202

  • Hospital Universitario Reina Sofia /ID# 131135

    Córdoba, 14004

  • Hospital Donostia /ID# 131144

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Hospital Universitario de la Princesa /ID# 131131

    Madrid, 28006

  • Hospital Universitario 12 de Octubre /ID# 131133

    Madrid, 28041

  • Hospital Universitario La Paz /ID# 131132

    Madrid, 28046

  • Hospital Universitario Virgen de la Victoria /ID# 131136

    Málaga, 29010

  • Hospital Universitario Central de Asturias /ID# 131138

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitari Son Espases /ID# 131140

    Palma de Mallorca, Balearic Islands, 07120

  • Hospital Unversitario Marques de Valdecilla /ID# 131141

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocio /ID# 131134

    Seville, 41013

  • Hospital Clinico Universitario Lozano Blesa /ID# 132292

    Zaragoza, 50009

Other trials in Spain

United Kingdom15 sites

  • University Hospitals Birmingham NHS Foundation Trust /ID# 131154

    Birmingham, B15 2TH

  • Duplicate_NHS Tayside /ID# 132300

    Dundee, DD2 1UB

  • NHS Lothian /ID# 134368

    Edinburgh, EH3 9HE

  • NHS Greater Glasgow and Clyde /ID# 131162

    Glasgow, Scotland, G12 0XH

  • Leeds Teaching Hospitals NHS Trust /ID# 132305

    Leeds, LS9 7TF

  • Barts Health NHS Trust /ID# 132302

    London, London, City of, E1 2ES

  • The Royal Free London NHS Foundation Trust /ID# 131159

    London, London, City of, NW3 2QG

  • King's College Hospital NHS Foundation Trusts /ID# 131157

    London, SE5 9RS

  • Duplicate_Nottingham University Nottingham University Hospitals NHS Trust /ID# 131155

    Nottingham, Nottinghamshire, NG5 1PB

  • University Hospital Plymouth NHS Trust /ID# 131160

    Plymouth, PL6 5FP

  • Duplicate_University Hospitals Dorset NHS Foundation Trust /ID# 132306

    Poole, Dorset, BH15 2JB

  • Portsmouth Hospitals University NHS Trust /ID# 131158

    Portsmouth, PO6 3LY

  • Northern Care Alliance NHS Group /ID# 131156

    Salford, M6 8HD

  • University Hospital Southampton NHS Foundation Trust /ID# 131161

    Southampton, Hampshire, SO16 6YD

  • St George's University Hospitals NHS Foundation Trust /ID# 132301

    Tooting, SW17 0QT

Other trials in United Kingdom

France12 sites

  • Hopital Jean Verdier /ID# 135877

    Bondy, 93140

  • CHU Grenoble - Hopital Michallon /ID# 131041

    La Tronche, 38700

  • CHU Limoges - Dupuytren 1 /ID# 131038

    Limoges, Franche-Comte, 87042

  • HCL - Hopital de la Croix-Rousse /ID# 131042

    Lyon, 69004

  • Hopital Saint Joseph /ID# 132177

    Marseille, Bouches-du-Rhone, 13008

  • Hopital Saint Eloi /ID# 131037

    Montpellier, Herault, 34295

  • CHU de Nantes, Hotel Dieu -HME /ID# 132179

    Nantes, Pays de la Loire Region, 44000

  • Duplicate_Hopital lArchet 2 /ID# 131040

    Nice, 06202

  • Hopital Haut-Lévêque /ID# 131036

    Pessac, Gironde, 33604

  • CHRU Pontchaillou /ID# 132173

    Rennes, 35033

  • CHU Strasbourg - Hopital Civil /ID# 132174

    Strasbourg, 67091

  • Hopital Universitaire Purpan Hopital Rangueil /ID# 131035

    Toulouse, 31059

Other trials in France

Germany12 sites

  • Medizinische Klinik mit Schwerpunkt Hepatologie und Gastroenterologie /ID# 131053

    Berlin, 13353

  • Zentru fur HIV und Heaptogastroenterologie /ID# 131052

    Düsseldorf, North Rhine-Westphalia, 40237

  • Universitaetsklinikum Essen /ID# 131048

    Essen, 45147

  • Universitaetsklinikum Frankfurt /ID# 131055

    Frankfurt am Main, Hesse, 60590

  • Universitaetsklinikum Freiburg /ID# 131044

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

  • Universitaetsklinikum Hamburg-Eppendorf (UKE) /ID# 131051

    Hamburg, 20246

  • Medizinische Hochschule Hannover /ID# 131054

    Hanover, 30625

  • Universitaetsklinik Heidelberg /ID# 134371

    Heidelberg, Baden-Wurttemberg, 69120

  • Gastroenterologische Gemeinschaftspraxis Herne /ID# 131050

    Herne, North Rhine-Westphalia, 44623

  • LMU Klinikum der Universitat Muchen /ID# 131049

    Munich, Bavaria, 81377

  • Centrum für interdisziplinaere Medizin /ID# 131046

    Münster, 48143

  • Universitaetsklinikum Tuebingen Medizinische Klinik /ID# 131045

    Tübingen, Baden-Wurttemberg, 72076

Other trials in Germany

Australia8 sites

  • Royal Adelaide Hospital /ID# 131002

    Adelaide, South Australia, 5000

  • St Vincent's Hospital Sydney /ID# 131001

    Darlinghurst, New South Wales, 2010

  • St Vincent's Hospital Melbourne /ID# 131000

    Fitzroy Melbourne, Victoria, 3065

  • Greenslopes Private Hospital /ID# 131003

    Greenslopes, Queensland, 4120

  • Royal Brisbane and Women's Hospital /ID# 131004

    Herston, Queensland, 4029

  • Nepean Hospital /ID# 130999

    Kingswood, New South Wales, 2747

  • The Royal Melbourne Hospital /ID# 130998

    Parkville, Victoria, 3050

  • Westmead Hospital /ID# 130997

    Westmead, New South Wales, 2145

Other trials in Australia

Turkey (Türkiye)7 sites

  • Hacettepe University Faculty of Medicine /ID# 131150

    Ankara, 06100

  • Ankara Univ Medical Faculty /ID# 131151

    Ankara, 06590

  • Uludag University Medical Faculty /ID# 132297

    Bursa, 16059

  • Istanbul University Istanbul Medical Faculty /ID# 131153

    Istanbul, 34093

  • Ege University Medical Faculty /ID# 132298

    Izmir, 35040

  • Izmir Tepecik Training and Research Hospital /ID# 134968

    Konak, İzmir, 35180

  • Karadeniz University /ID# 131152

    Trabzon, 61000

Other trials in Turkey (Türkiye)

Mexico6 sites

  • Instituto Nacional de Clencias Medicas y Nutricion Salvador Zubrian Departament /ID# 130975

    Distrito Federal, 14000

  • Cife /Id# 130974

    Guadalajara, Jalisco, 44160

  • CIF-BIOTEC/Medica Sur /ID# 134971

    Mexico City, 14050

  • ITESM campus Ciudad de Mexico /ID# 132383

    Mexico City, 14380

  • Hospital General de Tijuana /ID# 130972

    Tijuana, Estado de Baja California, 22680

  • Instituto Metropolitano de Inv /ID# 132201

    Tlalpan, 14308

Other trials in Mexico

Poland6 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku /ID# 131108

    Bialystok, Podlaskie Voivodeship, 15-276

  • Wojewodzki Szpital Obserwacyjno-Zakazny im. Tadeusza Browicza /ID# 131106

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-030

  • Wojewodzki Specjalistyczny Szpital im. dr. W. Bieganskiego /ID# 131107

    Lodz, Łódź Voivodeship, 91-347

  • Samodzielny Publiczny Szpital Kliniczny Nr 1 w Lublinie /ID# 131115

    Lublin, Lublin Voivodeship, 20-081

  • ID Clinic /ID# 131111

    Mysłowice, Silesian Voivodeship, 41-406

  • Wojewodzki Szpital Zakazny /ID# 131112

    Warsaw, Masovian Voivodeship, 01-201

Other trials in Poland

Bulgaria5 sites

  • Tokuda Hospital Sofia /ID# 131022

    Sofia, 1407

  • UMHAT Sveti Ivan Rilski /ID# 131026

    Sofia, 1431

  • Univ Hosp for Active Treat /ID# 131023

    Sofia, 1527

  • Diagnostic Consultative Center /ID# 131027

    Sofia, 1612

  • UMHAT Sveta Marina /ID# 131025

    Varna, 9010

Other trials in Bulgaria

Romania5 sites

  • Institutul Nat. de Boli Infectioase /ID# 131124

    Bucharest, 010825

  • SC Gastromedica SRL /ID# 131127

    Iași, 700506

  • Duplicate_Institutul National de Boli Infectioase Prof. Dr. Matei Bals /ID# 131120

    Sector 2, Bucharest, 021105

  • Institutul Clinic Fundeni /ID# 131121

    Sector 2, Bucharest, 022328

  • Spitalul Clinic de Boli Infectioase Si Pneumoftiziologie Dr. Victor Babes /Id# 131126

    Timișoara, Timiș County, 300310

Other trials in Romania

Israel4 sites

  • Rambam Health Care Campus /ID# 131090

    Haifa, 3109601

  • The Lady Davis Carmel Medical Center /ID# 131091

    Haifa, 34362

  • The Chaim Sheba Medical Center /ID# 131092

    Ramat Gan, Tel Aviv, 5265601

  • Tel Aviv Sourasky Medical Center /ID# 132182

    Tel Aviv, Tel Aviv, 6423906

Other trials in Israel

Portugal4 sites

  • Centro Hospitalar e Universitario de Coimbra, EPE /ID# 131119

    Coimbra, 3000-075

  • Centro Hospitalar Universitario Lisboa Central, EPE - Hospital dos Capuchos /ID# 131116

    Lisbon, 1169-050

  • Centro Hospitalar Universitário de Lisboa Norte, EPE - Hospital de Santa Maria /ID# 131118

    Lisbon, 1649-035

  • Centro Hospitalar Universitário do Porto, EPE - Hospital Santo António /ID# 131117

    Porto, 4099-001

Other trials in Portugal

Algeria3 sites

  • CHU Bab El Oued /ID# 145420

    Algiers, 16000

  • CHU Bologhine Hospital /ID# 145421

    Algiers, 16000

  • CHU Mustapha Bacha /ID# 132130

    Algiers, 16000

Other trials in Algeria

Austria3 sites

  • Medizinische Universitaet Graz /ID# 131018

    Graz, Styria, 8036

  • Ordensklinikum Linz GmbH Elisabethinen /ID# 131017

    Linz, Upper Austria, 4010

  • Medizinische Universitaet Wien /ID# 131015

    Vienna, State of Vienna, 1090

Other trials in Austria

Belgium3 sites

  • Cliniques Universitaires de Bruxelles Hopital Erasme /ID# 131020

    Brussels, Brussels Capital, 1070

  • Universitair Ziekenhuis Leuven /ID# 131021

    Leuven, Vlaams-Brabant, 3000

  • UCL Saint-Luc /ID# 131019

    Woluwe-Saint-Lambert, Brussels Capital, 1200

Other trials in Belgium

Denmark3 sites

  • Aarhus Univ Hospital, Skejby /ID# 131030

    Aarhus, 8200

  • Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 131031

    Hvidovre, Capital Region, 2650

  • Odense University Hospital /ID# 131029

    Odense C, Region Syddanmark, 5000

Other trials in Denmark

Greece3 sites

  • General University Hospital of Alexandroupolis /ID# 131056

    Alexandroupoli, 68100

  • General Hospital of Athens Ippokratio /ID# 131057

    Athens, Attica, 11527

  • General Hospital of Athens Laiko /ID# 131088

    Athens, Attica, 11527

Other trials in Greece

Ireland3 sites

  • Beaumont Hospital /ID# 131089

    Beaumont, Dublin, D09 XR63

  • St James Hospital /ID# 132180

    Dublin, Dublin, D08 NHY1

  • St Vincent's University Hospital /ID# 132181

    Elm Park, Dublin, D04 T6F4

Other trials in Ireland

Netherlands3 sites

  • Academisch Medisch Centrum /ID# 132205

    Amsterdam, 1105 AZ

  • Leids Universitair Medisch Centrum /ID# 132204

    Leiden, 2333 ZA

  • Erasmus Medisch Centrum /ID# 132206

    Rotterdam, South Holland, 3015 GD

Other trials in Netherlands

Norway3 sites

  • Akershus Universitetssykehus_MAIN /ID# 132212

    Lorenskog, Akershus, 1478

  • Stavanger University Hospital /ID# 132211

    Stavanger, 4068

  • St. Olavs Hospital HF /ID# 132213

    Trondheim, Sor-Trondelag, 7006

Other trials in Norway

Saudi Arabia3 sites

  • King Abdulaziz Medical City /ID# 145129

    Jeddah, 21423

  • Ministry Nat Guard Hosp Health /ID# 145126

    Riyadh, 11426

  • King Khalid University Hospita /ID# 132291

    Riyadh, 11472

Other trials in Saudi Arabia

Sweden3 sites

  • Sahlgrenska University Hospital /ID# 131147

    Gothenburg, Västra Götaland County, 413 45

  • Skane University hospital /ID# 131146

    Malmö, Skåne County, 214 28

  • Karolinska University Hospital Solna /ID# 131145

    Solna, Stockholm County, 171 64

Other trials in Sweden

Switzerland3 sites

  • Inselspital, Universitätsspital Bern /ID# 132294

    Bern, 3010

  • Kantonsspital St. Gallen /ID# 131148

    Sankt Gallen, Canton of St. Gallen, 9007

  • Universitätsspital Zürich /ID# 134881

    Zurich, Canton of Zurich, 8091

Other trials in Switzerland

Finland2 sites

  • Helsinki University Hospital /ID# 131034

    Helsinki, Uusimaa, 00290

  • Turku University Hospital /ID# 131032

    Turku, 20520

Other trials in Finland

About this study

Official title: An Open-Label, Multicenter Study to Evaluate Long-Term Outcomes With ABT-450/Ritonavir/ ABT-267 (ABT-450/r/ABT-267) and ABT-333 With or Without Ribavirin (RBV) in Adults With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ-I)

The purpose of this study was to evaluate the effect of treatment with ABT-450 co-formulated with ritonavir and ABT-267 (ABT-450/r/ABT-267) and ABT-333; 3-DAA regimen, with or without ribavirin (RBV) in adults with chronic hepatitis C virus genotype 1 (HCV GT1) infection.

Read the detailed description

This study (TOPAZ-I; M14-423), was a Phase 3b, open-label, multicenter study conducted outside of the United States which, together with its companion study TOPAZ-II (M14-222; NCT 02167945) conducted in the United States, was designed with the primary objective of assessing the effect of treatment response on long-term clinical outcomes in adults with chronic HCV GT1 infection with or without compensated cirrhosis, who were either treatment-naïve or interferon/ribavirin (IFN/RBV) treatment- experienced. In both studies, participants were treated with the 3-DAA regimen with or without RBV. This study consisted of a screening period of up to 42 days, a treatment period of either 12 weeks for HCV GT1a-infected subjects without cirrhosis and for HCV GT1b-infected subjects without cirrhosis or with compensated cirrhosis or 24 weeks for GT1a-infected participants with compensated cirrhosis, and a 260-week post-treatment period.

Being tested
ABT-450/r/ABT-267, ABT-333, Ribavirin (RBV)
Keywords
Hepatitis C Genotype 1, Compensated Cirrhosis, Cirrhosis, Naive, Hepatitis C, Hepatitis C Virus, Treatment-Experienced, Relapser, Null responder, Non responder
Medical subject headings
Hepatitis C, Chronic, Hepatitis C, Fibrosis

What participants receive

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

  • ABT-450/r/ABT-267Drug

    Also called ABT-450 also known as paritaprevir, ABT-267 also known as ombitasvir, Paritaprevir/ritonavir/ombitasvir also known as Viekirax

    Tablet for oral use

  • ABT-333Drug

    Also called ABT-333 also known as dasabuvir, ABT-333 also known as Exviera

    Tablet for oral use

  • Ribavirin (RBV)Drug

    Ribavirin was provided as 200 mg tablets, and dosed based on weight,1000 to 1200 mg divided twice daily per local label. For example, for participants weighing < 75 kg, RBV may have been taken orally as 2 tablets in the morning and 3 tablets in the evening which corresponds to a 1000 mg total daily dose. For participants weighing ≥ 75 kg, RBV may have been taken orally as 3 tablets in the morning and 3 tablets in the evening which corresponds to a 1200 mg total daily dose.

Study groups in NCT02219490
Study groupRoleWhat they receive
ABT-450/r/ABT-267 plus ABT-333 with or without ribavirin (RBV)ExperimentalParticipants with HCV GT1b without cirrhosis received the 3-DAA (ABT-450/ritonavir/ABT-267 and ABT-333) regimen: two 75 mg ABT-450/50 mg ritonavir/12.5 mg ABT-267 tablets taken orally every morning (QD) and one ABT-333 250 mg tablet taken orally twice a day (BID) for 12 weeks. Participants with HCV GT1a without cirrhosis and those with HCV GT1b with cirrhosis received the 3-DAA regimen and weight-based ribavirin (RBV; 1000 to 1200 mg divided twice daily per local label) for 12 weeks. Participants with HCV GT1a with cirrhosis received the 3-DAA regimen and weight-based RBV per local label for 24 weeks.
Receives: Drug: ABT-450/r/ABT-267; Drug: ABT-333; Drug: Ribavirin (RBV)

What is being measured

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

  1. All-Cause Death: Time to Event

    Time to all-cause death was defined as the number of days from the first day of study drug dosing for the participant to the date of death. All deaths were to be included, regardless of whether the death occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not die, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of all-cause death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).

    Measured: At Post-Treatment Weeks 52, 104, 156, 208, and 260

  2. Liver-Related Death: Time to Event

    Time to liver-related death was defined as days from the 1st day of study drug dosing for the subject to date of liver-related death. All liver-related deaths were to be included, regardless of whether the death occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at date of last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver-related death. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver-related death included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).

    Measured: At Post-Treatment Weeks 52, 104, 156, 208, and 260

  3. Liver Decompensation: Time to Event

    Time to liver decompensation was defined as number of days from the 1st day of study drug dosing for the participant to the date of liver decompensation. All liver decompensation was to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for liver decompensation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver decompensation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).

    Measured: At Post-Treatment Weeks 52, 104, 156, 208, and 260

  4. Liver Transplantation: Time to Event

    Time to liver transplantation was defined as days from 1st day of study drug dosing for subject to date of liver transplantation. All liver transplantation was to be included, whether it occurred while the subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, data was to be censored on 1st day of study drug dosing. All-cause death was a censoring event for liver transplantation. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of liver transplantation included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).

    Measured: At Post-Treatment Weeks 52, 104, 156, 208, and 260

  5. Hepatocellular Carcinoma: Time to Event

    Time to hepatocellular carcinoma (HCC) was defined as number of days from 1st day of study drug dosing for subject to date of hepatocellular carcinoma. All HCC was to be included, whether it occurred while subject was still taking study drug or had previously discontinued study drug. If the subject didn't experience the event of interest nor had died (all-cause death), their data was to be censored at the date of their last available assessment. For those with no post-baseline assessment, their data was to be censored on the 1st day of study drug dosing. All-cause death was a censoring event for HCC. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. The pre-specified analysis of hepatocellular carcinoma included pooled data from TOPAZ-I (this study) and the companion study TOPAZ-II (M14-222; NCT02167945).

    Measured: At Post-Treatment Weeks 52, 104, 156, 208, and 260

  6. All-Cause Death, Liver-Related Death, Liver Decompensation, Liver Transplantation, Hepatocellular Carcinoma: Time to Event

    Time to the composite of clinical outcomes is the time to the first occurrence of all-cause death, liver-related death, liver decompensation, liver transplantation, or hepatocellular carcinoma. All first occurrences were to be included, regardless of whether it occurred while the participant was still taking study drug or had previously discontinued study drug. If the participant did not experience any of these events, their data was to be censored at the date of their last available assessment of clinical outcomes. For participants with no post-baseline assessment, the participant's data was to be censored on the first day of study drug dosing. The event-free survival rates were estimated using Kaplan-Meier methodology and incidence estimates are presented with 95% confidence intervals. Pre-specified analysis included pooled data from this study and from TOPAZ-II; NCT02167945.

    Measured: At Post-Treatment Weeks 52, 104, 156, 208, and 260

Secondary outcomes (2)

  1. Change From Baseline in FibroScan Score by SVR12 Status

    The FibroScan test is a validated non-invasive test used to assess liver fibrosis in participants with chronic liver disease, and it was performed at study sites where it was available. For participants with Hepatitis C infection, a FibroScan score of 2-7 kPa indicates no liver scarring or mild scarring; a score of 8 or 9 is associated with moderate liver scarring; 9-14 indicates severe liver scarring; and 14 or higher is indicative of advanced liver scarring, cirrhosis. Negative changes from baseline indicate improvement in liver fibrosis.

    Measured: At the final treatment visit and Post-Treatment Weeks 12, 24, 52, 104, 156, 208, and 260

  2. Percentage of Participants With Sustained Virologic Response 12 Weeks Post-treatment (SVR12)

    SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) less than the lower limit of quantification (LLOQ) 12 weeks after the last actual dose of study drug. Flanking imputation, where applicable, was used to impute missing data. After applying flanking imputation, if there was no value in the window but there was an HCV RNA value from a local laboratory present, then it was to be imputed into the SVR window. Otherwise, participants with missing data were counted as failures.

    Measured: 12 weeks after the last actual dose of study drug

Timeline

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

  1. First posted19 Aug 2014 (estimated)
  2. Study start30 Oct 2014
  3. Primary completion13 May 2021
  4. Study completion13 May 2021

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 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,596 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02219490
Sponsor's protocol ID
M14-423
Other IDs
2014-001022-14, 2014
Acronym
TOPAZ-I
Status last verified
Jun 2022
First submitted
15 Aug 2014
Last updated
7 Apr 2023
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing ABT-450/r/ABT-267, ABT-333 and Ribavirin (RBV) in people with Chronic Hepatitis C Virus (HCV) Infection Genotype 1, run by AbbVie at 187 sites in 27 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 5 inclusion and 5 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 7 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 187 sites in Italy, Russia, Canada, Spain, United Kingdom and 22 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 7 Apr 2023). 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?

All-Cause Death: Time to Event (time frame: At Post-Treatment Weeks 52, 104, 156, 208, and 260). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02219490.

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 7 Apr 2023.

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