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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01278134
Recruitment Status : Completed
First Posted : January 17, 2011
Last Update Posted : November 2, 2016
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:

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.

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 170 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Study Start Date : February 2011
Actual Primary Completion Date : October 2012
Actual Study Completion Date : October 2012

Resource links provided by the National Library of Medicine

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: RO5024048
1000 mg bid orally, up to 24 weeks

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

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

Secondary Outcome Measures :
  1. Virological response (HCV RNA measured by Roche COBAS Taqman HCV test) [ Time Frame: up to 48 weeks ]
  2. 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 ]
  3. 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 ]
  4. Pharmacokinetics: Plasma concentrations of danoprevir, ritonavir, RO4995855 (parent drug of RO5024048) and ribavirin [ Time Frame: up to 24 weeks ]
  5. Viral resistance: HCV RNA sequencing and phenotypic analyses [ Time Frame: up to 48 weeks ]
  6. Effect of interleukin 28B genotype on efficacy: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test) [ Time Frame: 1.5 years ]
  7. Quality of life: SF-36 questionnaire, Fatigue Severity Scale [ Time Frame: up to 36 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01278134

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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
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Study Director: Clinical Trials Hoffmann-La Roche
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Hoffmann-La Roche Identifier: NCT01278134    
Other Study ID Numbers: PP25213
First Posted: January 17, 2011    Key Record Dates
Last Update Posted: November 2, 2016
Last Verified: November 2016
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Hepatitis, Chronic
Peginterferon alfa-2a
HIV Protease Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-HIV Agents
Anti-Retroviral Agents
Antiviral Agents
Anti-Infective Agents
Cytochrome P-450 CYP3A Inhibitors
Cytochrome P-450 Enzyme Inhibitors