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Hepatitis C, ChronicNCT01168856

An Observational Study on Long-Term Persistence of Resistant Mutations And Durability of Sustained Virological Response in Patients With Chronic Hepatitis C Treated With Direct Acting Antiviral (DAA)- Containing Regimens

An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 126 sites in 15 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic
How many people
734 participants
Where
126 sitesin 15 countries
Study dates
Sep 2010to Apr 2015
Phase
Observational
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

Study population: Chronic hepatitis C patients having received direct acting antiviral treatment in donor protocol

Who may be able to join

  • adult patients, >/=18 years of age
  • chronic hepatitis C
  • participation in Roche DAA treatment protocol for CHC infection
  • DAA-associated resistant mutations persisting through to last evaluation in donor protocol , or partial viral response or viral load rebound while on RO5024048 treatment, or sustained virological response >/= 20 weeks after last dose of study medication in donor study

Who cannot join

  • For patients participating in DAA resistance monitoring: Initiation of treatment after participation in the donor protocol for which there is evidence of cross-resistance to donor protocol DAA
  • For patients participating in DAA SVR durability: Treatment with any anti-HVC therapy since establishing SVR in the donor study

Trial locations and contacts

126 sites in 15 countries.

126 sites in 15 countries

United States34 sites

  • Study site

    Atlanta, Georgia, 30309

  • Study site

    Aurora, Colorado, 80045

  • Study site

    Bradenton, Florida, 34209

  • Study site

    Chicago, Illinois, 60637

  • Study site

    Dallas, Texas, 75246

  • Study site

    Decatur, Georgia, 30033

  • Study site

    Detroit, Michigan, 48202

  • Study site

    Englewood, Colorado, 80113

  • Study site

    Hillsborough, New Jersey, 08844

  • Study site

    Honolulu, Hawaii, 96814

  • Study site

    Houston, Texas, 77030

  • Study site

    Indianapolis, Indiana, 46202

  • Study site

    Kansas City, Kansas, 66160-7222

  • Study site

    Kansas City, Missouri, 64131

  • Study site

    La Jolla, California, 92037-1030

  • Study site

    Lebanon, New Hampshire, 03756

  • Study site

    Long Beach, California, 90822

  • Study site

    Manhasset, New York, 11030

  • Study site

    Marietta, Georgia, 30060

  • Study site

    Nashville, Tennessee, 37211

  • Study site

    New Orleans, Louisiana, 70112

  • Study site

    New York, New York, 10003

  • Study site

    New York, New York, 10021

  • Study site

    Newark, New Jersey, 07102

  • Study site

    Newport News, Virginia, 23602

  • Study site

    Providence, Rhode Island, 02905

  • Study site

    Richmond, Virginia, 23249

  • Study site

    Sacramento, California, 95817

  • Study site

    Sacramento, California, 95825

  • Study site

    San Antonio, Texas, 78212

  • Study site

    San Antonio, Texas, 78234

  • Study site

    San Diego, California, 92103-8465

  • Study site

    San Francisco, California, 94115

  • Study site

    Vancouver, Washington, 98604

Other trials in United States

Canada14 sites

  • Study site

    Calgary, Alberta, T2N 4Z6

  • Study site

    Edmonton, Alberta, T6G 2B7

  • Study site

    Edmonton, Alberta, T6L5X8

  • Study site

    London, Ontario, N6A 5A5

  • Study site

    Montreal, Quebec, H3A 1A1

  • Study site

    Ottawa, Ontario, K1H 8L6

  • Study site

    Toronto, Ontario, M5G 1L7

  • Study site

    Toronto, Ontario, M5T 2S8

  • Study site

    Vancouver, British Columbia, V5Z 1H2

  • Study site

    Vancouver, British Columbia, V5Z 1M9

  • Study site

    Vancouver, British Columbia, V6Z 2C7

  • Study site

    Vancouver, British Columbia, V6Z 2K5

  • Study site

    Victoria, British Columbia, V8V 3P9

  • Study site

    Winnipeg, Manitoba, R3E 3P4

Other trials in Canada

France13 sites

  • Study site

    Clichy, 92118

  • Study site

    Créteil, 94010

  • Study site

    Lille, 59037

  • Study site

    Marseille, 13285

  • Study site

    Montpellier, 34094

  • Study site

    Montpellier, 34295

  • Study site

    Nice, 06202

  • Study site

    Paris, 75651

  • Study site

    Paris, 75679

  • Study site

    Pessac, 33604

  • Study site

    Rennes, 35033

  • Study site

    Toulouse, 31059

  • Study site

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Spain13 sites

  • Study site

    A Coruña, La Coruña, 15006

  • Study site

    Badalona, Barcelona, 08915

  • Study site

    Barcelona, Barcelona, 08003

  • Study site

    Barcelona, Barcelona, 08035

  • Study site

    Madrid, Madrid, 28029

  • Study site

    Madrid, Madrid, 28034

  • Study site

    Madrid, Madrid, 28222

  • Study site

    Palma de Mallorca, Balearic Islands, 07010

  • Study site

    Pontevedra, Pontevedra, 36071

  • Study site

    San Cristóbal de La Laguna, Tenerife, 38320

  • Study site

    Santander, Cantabria, 39008

  • Study site

    Seville, Sevilla, 41014

  • Study site

    Valencia, Valencia, 46014

Other trials in Spain

Australia10 sites

  • Study site

    Adelaide, South Australia, 5000

  • Study site

    Darlinghurst, New South Wales, 2010

  • Study site

    Greenslopes, Queensland, 4120

  • Study site

    Herston, Queensland, 4029

  • Study site

    Kingswood, New South Wales, 2747

  • Study site

    Melbourne, Victoria, 3181

  • Study site

    Melbourne, Victoria, 3186

  • Study site

    Sydney, New South Wales, 2050

  • Study site

    Westmead, New South Wales, 2145

  • Study site

    Woolloongabba, Queensland, 4102

Other trials in Australia

Italy8 sites

  • Study site

    Bari, Apulia, 70124

  • Study site

    Bologna, Emilia-Romagna, 40138

  • Study site

    Milan, Lombardy, 20121

  • Study site

    Milan, Lombardy, 20162

  • Study site

    Naples, Campania, 80131

  • Study site

    Pavia, Lombardy, 27100

  • Study site

    Pisa, Tuscany, 56124

  • Study site

    Turin, Piedmont, 10126

Other trials in Italy

Poland8 sites

  • Study site

    Bydgoszcz, 85-030

  • Study site

    Chorzów, 41-500

  • Study site

    Lodz, 91-347

  • Study site

    Lodz, 91-357

  • Study site

    Mysłowice, 41-400

  • Study site

    Warsaw, 01-201

  • Study site

    Warsaw, 02-507

  • Study site

    Wroclaw, 50-349

Other trials in Poland

United Kingdom8 sites

  • Study site

    Dorset, BH7 7DW

  • Study site

    Dundee, DD1 9SY

  • Study site

    London, E1 1BB

  • Study site

    London, SE5 9RS

  • Study site

    London, SW17 0QT

  • Study site

    London, W2 1NY

  • Study site

    Manchester, M8 5RB

  • Study site

    Nottingham, NG7 2UH

Other trials in United Kingdom

Germany6 sites

  • Study site

    Berlin, 10969

  • Study site

    Berlin, 13353

  • Study site

    Frankfurt am Main, 60590

  • Study site

    Hamburg, 20099

  • Study site

    Hanover, 30625

  • Study site

    München, 81377

Other trials in Germany

Brazil3 sites

  • Study site

    Porto Alegre, Rio Grande do Sul, 90035-003

  • Study site

    Ribeirão Preto, São Paulo, 14049-900

  • Study site

    Salvador, Estado de Bahia, 40210-341

Other trials in Brazil

Mexico3 sites

  • Study site

    Guadalajara, 44280

  • Study site

    Guadalajara, 44650

  • Study site

    Monterrey, 64710

Other trials in Mexico

New Zealand3 sites

  • Study site

    Christchurch, 8011

  • Study site

    Dunedin, 9016

  • Study site

    Grafton, 1010

Other trials in New Zealand

Austria1 site

  • Study site

    Vienna, 1080

Other trials in Austria

Puerto Rico1 site

  • Study site

    San Juan, 00927

Other trials in Puerto Rico

Slovakia1 site

  • Study site

    Bratislava, 831 01

Other trials in Slovakia

About this study

Official title: A Long-term Monitoring Study to Evaluate the Persistence of Direct Antiviral (DAA) Treatment Resistant Mutations or the Durability of Sustained Virological Response (SVR) in Patients Treated With DAA Containing Regimens for Chronic Hepatitis C Infections (CHC)

This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up to 5 scheduled monitoring visits for blood sampling during an observational period of up to 36 months.

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.

Study groups in NCT01168856
Study groupRoleWhat they receive
CohortNot described

What is being measured

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

  1. Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3

    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 International Units per milliliter [IU/mL]).

    Measured: Month 3

  2. Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 6

    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

    Measured: Month 6

  3. Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 9

    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

    Measured: Month 9

  4. Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 12

    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

    Measured: Month 12

  5. Percentage of Participants With the Detectable HCV RNA Results in Resistance Monitoring Arm at Month 18

    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

    Measured: Month 18

  6. HCV RNA Levels in Resistance Monitoring Arm at Month 3

    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

    Measured: Month 3

  7. HCV RNA Levels in Resistance Monitoring Arm at Month 6

    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

    Measured: Month 6

  8. HCV RNA Levels in Resistance Monitoring Arm at Month 9

    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

    Measured: Month 9

  9. HCV RNA Levels in Resistance Monitoring Arm at Month 12

    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

    Measured: Month 12

  10. HCV RNA Levels in Resistance Monitoring Arm at Month 18

    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

    Measured: Month 18

  11. Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 3

    Any abnormalities in systolic blood pressure (units: millimeters of Mercury [Hg] [mmHg]) were reported at the discretion of principal investigator.

    Measured: Month 3

  12. Systolic Blood Pressure in Resistance Monitoring Arm at Month 6

    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

    Measured: Month 6

  13. Systolic Blood Pressure in Resistance Monitoring Arm at Month 9

    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

    Measured: Month 9

  14. Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 12

    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

    Measured: Month 12

  15. Mean Systolic Blood Pressure in Resistance Monitoring Arm at Month 18

    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

    Measured: Month 18

  16. Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 3

    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

    Measured: Month 3

  17. Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 6

    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

    Measured: Month 6

  18. Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 9

    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

    Measured: Month 9

  19. Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 12

    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

    Measured: Month 12

  20. Mean Diastolic Blood Pressure in Resistance Monitoring Arm at Month 18

    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

    Measured: Month 18

  21. Mean Pulse Rate in Resistance Monitoring Arm at Month 3

    Any abnormalities in pulse rate were reported at the discretion of principal investigator.

    Measured: Month 3

  22. Mean Pulse Rate in Resistance Monitoring Arm at Month 6

    Any abnormalities in pulse rate were reported at the discretion of principal investigator.

    Measured: Month 6

  23. Mean Pulse Rate in Resistance Monitoring Arm at Month 9

    Any abnormalities in pulse rate were reported at the discretion of principal investigator.

    Measured: Month 9

  24. Mean Pulse Rate in Resistance Monitoring Arm at Month 12

    Any abnormalities in pulse rate were reported at the discretion of principal investigator.

    Measured: Month 12

  25. Mean Pulse Rate in Resistance Monitoring Arm at Month 18

    Any abnormalities in pulse rate were reported at the discretion of principal investigator.

    Measured: Month 18

  26. Percentage of Participants Who Received Anti-HCV Medications in Resistance Monitoring Arm

    Percentage of participants who received any anti-HCV medication during the monitoring period was reported.

    Measured: Up to 18 months

  27. Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 6

    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

    Measured: Month 6

  28. Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 12

    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

    Measured: Month 12

  29. Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 24

    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

    Measured: Month 24

  30. Percentage of Participants With the Detectable HCV RNA Results in SVR Durability Monitoring Arm at Month 36

    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

    Measured: Month 36

  31. Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 6

    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

    Measured: Month 6

  32. Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 12

    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

    Measured: Month 12

  33. Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 24

    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

    Measured: Month 24

  34. Mean HCV RNA Levels in SVR Durability Monitoring Arm at Month 36

    Serum HCV RNA concentration was determined using the Roche COBAS TaqMan HCV Test (Detection limit = 15 IU/mL).

    Measured: Month 36

  35. Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 6

    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

    Measured: Month 6

  36. Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 12

    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

    Measured: Month 12

  37. Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 24

    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

    Measured: Month 24

  38. Mean Systolic Blood Pressure in SVR Durability Monitoring Arm at Month 36

    Any abnormalities in systolic blood pressure were reported at the discretion of principal investigator.

    Measured: Month 36

  39. Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 6

    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

    Measured: Month 6

  40. Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 12

    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

    Measured: Month 12

  41. Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 24

    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

    Measured: Month 24

  42. Mean Diastolic Blood Pressure in SVR Durability Monitoring Arm at Month 36

    Any abnormalities in diastolic blood pressure were reported at the discretion of principal investigator.

    Measured: Month 36

  43. Mean Pulse Rate in SVR Durability Monitoring Arm at Month 6

    Any abnormalities in pulse rate were reported at the discretion of principal investigator.

    Measured: Month 6

  44. Mean Pulse Rate in SVR Durability Monitoring Arm at Month 12

    Any abnormalities in pulse rate were reported at the discretion of principal investigator.

    Measured: Month 12

  45. Mean Pulse Rate in SVR Durability Monitoring Arm at Month 24

    Any abnormalities in pulse rate were reported at the discretion of principal investigator.

    Measured: Month 24

  46. Mean Pulse Rate in SVR Durability Monitoring Arm at Month 36

    Any abnormalities in pulse rate were reported at the discretion of principal investigator.

    Measured: Month 36

  47. Number of Participants With Danoprevir (DNV) Resistance Status-Population Sequencing

    Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.

    Results are reported as per donor protocol. Category 1: Number of participants with loss of resistance in NV22688. A total of 99 participants with resistance at the end of donor study by population sequencing were included in this analysis.

    Category 2: Number of participants with no loss of resistance in NV22688. A total of 33 participants with resistance at the end of donor study by population sequencing were included in this analysis.

    Category 3: Number of participants with loss of resistance in donor study. A total of 30 participants with no DNV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.

    Measured: Month 3-18

  48. Number of Participants With DNV Resistance Status-Clonal Sequencing

    Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of DNV resistance or without loss of DNV resistance.

    Category 1-Number of participants with loss of resistance in NV22688. A total of 64 participants with loss of resistance in NV22688 were included in this analysis.

    Category 2-Number of participants with no loss of resistance in NV22688. A total of 35 participants with no loss of resistance in NV22688 were included in this analysis.

    Category 3-Number of participants with loss of resistance in donor study. A total of 26 participants who had no DNV resistance at the end of donor study were analyzed by clonal sequencing in NV22688. Three participants from donor studies WV21913, NP28266 and NP27946, respectively were not analyzed by clonal sequencing in NV22688 as loss of resistance mutations was demonstrated by clonal sequencing in donor study.

    Measured: Month 3-18

  49. Number of Participants With Boceprevir (BOC) or Telaprevir (TVR) Resistance Status-Population Sequencing

    Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.

    Category 1-Number of participants with loss of resistance in NV22688. A total of 6 participants with resistance at the end of donor study by population sequencing were included in this analysis.

    Category 2-Number of participants with no loss resistance in NV22688. One participant with resistance at the end of donor study by population sequencing was included in this analysis.

    Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants with no BOC or TVR resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.

    Measured: Month 3-18

  50. Number of Participants With BOC or TVR Resistance Status-Clonal Sequencing

    Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of BOC or TVR resistance or without loss of BOC or TVR resistance.

    Category 1-Number of participants with loss of resistance in NV22688. A total of 3 participants with loss of resistance in NV22688 were included in this analysis.

    Category 2-Number of participants with no loss of resistance in NV22688. A total of 3 participants with no loss of resistance in NV22688 were included in this analysis.

    Category 3-Number of participants with loss of resistance in donor study. A total of 2 participants who had no resistance at the end of donor study were analyzed by clonal sequencing in NV22688.

    Measured: Month 3-18

  51. Number of Participants With Setrobuvir (STV) Resistance Status-Population Sequencing

    Population sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.

    Category 1-Number of participants with loss of resistance in NV22688. A total of 5 participants with resistance at the end of donor study by population sequencing were included in this analysis.

    Category 2-Number of participants with no loss resistance in NV22688. A total of 3 participants with resistance at the end of donor study by population sequencing were included in this analysis.

    Category 3-Number of participants with loss of resistance in donor study. A total of 3 participants with no STV resistance at the end of donor study by population sequencing enrolled in NV22688 were included in this analysis.

    Measured: Month 3-18

  52. Number of Participants With STV Resistance Status-Clonal Sequencing

    Clonal sequencing was used for determination of loss of resistance status. Resistance status was reported as either with loss of STV resistance or without loss of STV resistance.

    Category 1-Number of participants with loss of resistance in NV22688. One participant with loss of resistance in NV22688 was included in this analysis.

    Category 2-Number of participants with no loss of resistance in NV22688. A total of 4 participants with no loss of resistance in NV22688 were included in this analysis.

    Category 3-Number of participants with loss of resistance in donor study. One participant with loss of resistance, analyzed by clonal sequencing in NV22688.

    Category 4-Number of participants with loss of resistance in donor study. Two participants with no loss of resistance, analyzed by clonal sequencing in NV22688.

    Measured: Month 3-18

  53. Number of Participants Who Had Received Mericitabine (MCB)-Based Regimen and Enrolled in NV22688

    Population sequencing was used for determination of loss of resistance status. Results are reported as per donor protocol.

    Measured: Month 18

Timeline

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

  1. First posted23 Jul 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionApr 2015
  4. Study completionApr 2015

Why it stopped: This study was terminated due to the decrease in percentage of participants.

Resources

More details

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

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
734 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01168856
Sponsor's protocol ID
NV22688
Other IDs
2009-016560-36, 2009
Status last verified
Feb 2016
First submitted
15 Jul 2010
Last updated
11 Mar 2016

Questions about this trial

What is this clinical trial studying?

An observational study of Hepatitis C, Chronic, run by Hoffmann-La Roche at 126 sites in 15 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 4 inclusion and 2 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: stopped early, as of the sponsor's last update on 11 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 126 sites in United States, Canada, France, Spain, Australia and 10 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Mar 2016). 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?

Percentage of Participants With the Detectable HCV Ribonucleic Acid (RNA) Results in Resistance Monitoring Arm at Month 3 (time frame: Month 3). The study lists 53 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 NCT01168856.

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 11 Mar 2016.

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