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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)

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: January 14, 2011
Last updated: November 3, 2014
Last verified: November 2014

This multicenter, randomized, double-blind, parallel group study will evaluate t he safety and efficacy of the combination RO5024048 and ritonavir-boosted danopr evir with and without Copegus (ribavirin) in patients with chronic hepatitis C g enotype 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 ora lly 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 t reatment. The anticipated time on study treatment is up to 24 weeks plus a 24-we ek follow-up. As of 29. September 2011, Arm B patients (placebo-containing arm) will be offered, in conjunction with the current treatment, Pegasys (peginterfe ron alfa-2a) 180 mcg subcutaneously weekly plus Copegus 1000mg or 1200 mg orally daily for 24 weeks, with a 24-week follow-up.

Condition Intervention Phase
Hepatitis C, Chronic
Drug: Copegus placebo
Drug: danoprevir
Drug: peginterferon alfa-2a [Pegasys]
Drug: ribavirin [Copegus]
Drug: ritonavir
Drug: RO5024048
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Sustained virological response, defined as undetectable HVC RNA measured by Roche COBAS TaqMan HCV test [ Time Frame: 24 weeks after end of treatment ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Virological response (HCV RNA measured by Roche COBAS Taqman HCV test) [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Plasma concentrations of danoprevir, ritonavir, RO4995855 (parent drug of RO5024048) and ribavirin [ Time Frame: up to 24 weeks ] [ Designated as safety issue: No ]
  • Viral resistance: HCV RNA sequencing and phenotypic analyses [ Time Frame: up to 48 weeks ] [ Designated as safety issue: No ]
  • Effect of interleukin 28B genotype on efficacy: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test) [ Time Frame: 1.5 years ] [ Designated as safety issue: No ]
  • Quality of life: SF-36 questionnaire, Fatigue Severity Scale [ Time Frame: up to 36 weeks ] [ Designated as safety issue: No ]

Enrollment: 170
Study Start Date: February 2011
Study Completion Date: October 2012
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A Drug: danoprevir
100 mg bid orally, up to 24 weeks
Drug: ribavirin [Copegus]
1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
Drug: ritonavir
100 mg bid orally, up to 24 weeks
Drug: RO5024048
1000 mg bid orally, up to 24 weeks
Experimental: B Drug: Copegus placebo
1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
Drug: danoprevir
100 mg bid orally, up to 24 weeks
Drug: ritonavir
100 mg bid orally, up to 24 weeks
Drug: RO5024048
1000 mg bid orally, up to 24 weeks
Experimental: 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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01278134

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

No publications provided by Hoffmann-La Roche

Additional publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Hoffmann-La Roche Identifier: NCT01278134     History of Changes
Other Study ID Numbers: PP25213, 2010-022067-35
Study First Received: January 14, 2011
Last Updated: November 3, 2014
Health Authority: France: Ministry of Health

Additional relevant MeSH terms:
Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Digestive System Diseases
Enterovirus Infections
Flaviviridae Infections
Hepatitis, Chronic
Hepatitis, Viral, Human
Liver Diseases
Picornaviridae Infections
RNA Virus Infections
Virus Diseases
Peginterferon alfa-2a
Anti-HIV Agents
Anti-Infective Agents
Anti-Retroviral Agents
Antineoplastic Agents
Antiviral Agents
Enzyme Inhibitors
HIV Protease Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protease Inhibitors
Therapeutic Uses processed this record on November 20, 2014