A Study of RO5024048 in Combination With Ritonavir-Boosted Danoprevir With or Without Copegus (Ribavirin) in Interferon-Naïve Patients With Chronic Hepatitis C Genotype 1 (INFORM-SVR)

November 1, 2016 updated by: Hoffmann-La Roche

INFORM-SVR: A Randomized, Multi-Center Study of Interferon-Free Treatment With a Combination of a Polymerase Inhibitor (RO5024048) and a Ritonavir Boosted HCV Protease Inhibitor (RO5190591/r, DNV/r) With or Without Copegus® in Interferon Naïve HCV Genotype 1 Infected Patients

This multicenter, randomized, double-blind, parallel group study will evaluate the safety and efficacy of the combination RO5024048 and ritonavir-boosted danoprevir with and without Copegus (ribavirin) in patients with chronic hepatitis C genotype 1. In arm A and B, interferon treatment-naïve patients will receive 1000 mg RO5024048 orally twice daily and 100 mg danoprevir with 100 mg ritonavir orally twice daily plus either Copegus (1000 mg or 1200 mg orally daily) or placebo for 12 weeks. Depending on viral response and treatment arm patients will be re-randomized to continue assigned treatment for additional 12 weeks or stop all treatment. The anticipated time on study treatment is up to 24 weeks plus a 24-week follow-up.

As of 29. September 2011, Arm B patients (placebo-containing arm) will be offered, in conjunction with the current treatment, Pegasys (peginterferon alfa-2a) 180 mcg subcutaneously weekly plus Copegus 1000mg or 1200 mg orally daily for 24 weeks, with a 24-week follow-up.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

170

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clichy, France, 92118
      • Creteil, France, 94010
      • Lille, France, 59037
      • Marseille, France, 13285
      • Montpellier, France, 34295
      • Paris, France, 75651
  • Germany
      • Berlin, Germany, 13353
      • Berlin, Germany, 10969
      • Frankfurt Am Main, Germany, 60590
      • Hamburg, Germany, 20099
      • Hannover, Germany, 30625
      • Kiel, Germany, 24146
      • Leipzig, Germany, 04103
  • New Zealand
      • Grafton, New Zealand, 1010
  • United States
    • California
      • La Jolla, California, United States, 92037-1030
      • Sacramento, California, United States, 95817
    • Florida
      • Orlando, Florida, United States, 32809
    • Georgia
      • Marietta, Georgia, United States, 30060
    • Hawaii
      • Honolulu, Hawaii, United States, 96817
      • Honolulu, Hawaii, United States, 96814
    • Illinois
      • Chicago, Illinois, United States, 60637
    • Indiana
      • Indianapolis, Indiana, United States, 46202
    • Maryland
      • Lutherville, Maryland, United States, 21093
    • Michigan
      • Detroit, Michigan, United States, 48202
    • New Jersey
      • Newark, New Jersey, United States, 07102
    • New Mexico
      • Albuquerque, New Mexico, United States, 87131
    • New York
      • New York, New York, United States, 10021
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
    • Tennessee
      • Nashville, Tennessee, United States, 37211
    • Texas
      • Houston, Texas, United States, 77030
    • Virginia
      • Newport News, Virginia, United States, 23602
    • Washington
      • Vancouver, Washington, United States, 98664

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patient, >/= 18 years of age
  • Chronic Hepatitis C of >/= 6 months duration at screening
  • HCV genotype 1 and quantifiable HCV RNA at screening (Roche COBAS TaqMan HCV test)
  • Naïve for treatment with interferon (pegylated or non-pegylated)
  • Body Mass Index (BMI) 18-35 inclusive, minimum weight 45 kg
  • Females of child-bearing potential and males with female partners of childbearing potential must use 2 forms of effective non-hormonal contraception

Exclusion Criteria:

  • Pregnant or lactating women and males with female partners who are pregnant or lactating
  • Decompensated liver disease or impaired liver function
  • Cirrhosis or incomplete/transition to cirrhosis
  • Non-hepatitis C chronic liver disease
  • Hepatitis B or HIV infection
  • History of neoplastic disease within the last 5 years, except for localized or in situ carcinoma of the skin
  • History of pre-existing renal disease (except for nephrolithiasis) or severe cardiac disease
  • History of drug or alcohol abuse within the last year or alcohol consumption of > 2 units per day; cannabinoid use is excepted

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Arm B Extension
All patients in treatment arm B were offered to receive Pegasys/Cogepus therapy for an additional 24 weeks.
Drug: peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 24 weeks
Drug: ribavirin [Copegus]
1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
Experimental: RO5024048 & ritonavir-boosted danoprevir without Ribavirin (B)
Drug: Copegus placebo
1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
Drug: RO5024048
1000 mg bid orally, up to 24 weeks
Drug: danoprevir
100 mg bid orally, up to 24 weeks
Drug: ritonavir
100 mg bid orally, up to 24 weeks
Experimental: RO5024048 and ritonavir-boosted danoprevir with Ribavirin (A)
Drug: ribavirin [Copegus]
1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
Drug: RO5024048
1000 mg bid orally, up to 24 weeks
Drug: danoprevir
100 mg bid orally, up to 24 weeks
Drug: ritonavir
100 mg bid orally, up to 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Sustained virological response, defined as undetectable HVC RNA measured by Roche COBAS TaqMan HCV test
Time Frame: 24 weeks after end of treatment
24 weeks after end of treatment
Safety: Incidence of adverse events
Time Frame: 1.5 years
1.5 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Virological response (HCV RNA measured by Roche COBAS Taqman HCV test)
Time Frame: up to 48 weeks
up to 48 weeks
Impact of Copegus (ribavirin) on efficacy of the direct-acting antiviral combination regimen: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test)
Time Frame: 1.5 years
1.5 years
Comparison of 12 and 24 weeks of treatment duration: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test)
Time Frame: 1.5 years
1.5 years
Pharmacokinetics: Plasma concentrations of danoprevir, ritonavir, RO4995855 (parent drug of RO5024048) and ribavirin
Time Frame: up to 24 weeks
up to 24 weeks
Viral resistance: HCV RNA sequencing and phenotypic analyses
Time Frame: up to 48 weeks
up to 48 weeks
Effect of interleukin 28B genotype on efficacy: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test)
Time Frame: 1.5 years
1.5 years
Quality of life: SF-36 questionnaire, Fatigue Severity Scale
Time Frame: up to 36 weeks
up to 36 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hoffmann-La Roche

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

October 1, 2012

Study Completion (Actual)

October 1, 2012

Study Registration Dates

First Submitted

January 14, 2011

First Submitted That Met QC Criteria

January 14, 2011

First Posted (Estimate)

January 17, 2011

Study Record Updates

Last Update Posted (Estimate)

November 2, 2016

Last Update Submitted That Met QC Criteria

November 1, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PP25213
  • 2010-022067-35

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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