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)
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
2 other identifiers
interventional
170
4 countries
32
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Feb 2011
32 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2011
CompletedFirst Posted
Study publicly available on registry
January 17, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedNovember 2, 2016
November 1, 2016
1.7 years
January 14, 2011
November 1, 2016
Conditions
Outcome Measures
Primary Outcomes (2)
Sustained virological response, defined as undetectable HVC RNA measured by Roche COBAS TaqMan HCV test
24 weeks after end of treatment
Safety: Incidence of adverse events
1.5 years
Secondary Outcomes (7)
Virological response (HCV RNA measured by Roche COBAS Taqman HCV test)
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)
1.5 years
Comparison of 12 and 24 weeks of treatment duration: viral response (HCV RNA measured by Roche COBAS TaqMan HCV test)
1.5 years
Pharmacokinetics: Plasma concentrations of danoprevir, ritonavir, RO4995855 (parent drug of RO5024048) and ribavirin
up to 24 weeks
Viral resistance: HCV RNA sequencing and phenotypic analyses
up to 48 weeks
- +2 more secondary outcomes
Study Arms (3)
Arm B Extension
EXPERIMENTALAll patients in treatment arm B were offered to receive Pegasys/Cogepus therapy for an additional 24 weeks.
RO5024048 & ritonavir-boosted danoprevir without Ribavirin (B)
EXPERIMENTALRO5024048 and ritonavir-boosted danoprevir with Ribavirin (A)
EXPERIMENTALInterventions
1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
1000 mg bid orally, up to 24 weeks
100 mg bid orally, up to 24 weeks
1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
100 mg bid orally, up to 24 weeks
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (32)
Unknown Facility
La Jolla, California, 92037-1030, United States
Unknown Facility
Sacramento, California, 95817, United States
Unknown Facility
Orlando, Florida, 32809, United States
Unknown Facility
Marietta, Georgia, 30060, United States
Unknown Facility
Honolulu, Hawaii, 96814, United States
Unknown Facility
Honolulu, Hawaii, 96817, United States
Unknown Facility
Chicago, Illinois, 60637, United States
Unknown Facility
Indianapolis, Indiana, 46202, United States
Unknown Facility
Lutherville, Maryland, 21093, United States
Unknown Facility
Detroit, Michigan, 48202, United States
Unknown Facility
Newark, New Jersey, 07102, United States
Unknown Facility
Albuquerque, New Mexico, 87131, United States
Unknown Facility
New York, New York, 10021, United States
Unknown Facility
Providence, Rhode Island, 02905, United States
Unknown Facility
Nashville, Tennessee, 37211, United States
Unknown Facility
Houston, Texas, 77030, United States
Unknown Facility
Newport News, Virginia, 23602, United States
Unknown Facility
Vancouver, Washington, 98664, United States
Unknown Facility
Clichy, 92118, France
Unknown Facility
Créteil, 94010, France
Unknown Facility
Lille, 59037, France
Unknown Facility
Marseille, 13285, France
Unknown Facility
Montpellier, 34295, France
Unknown Facility
Paris, 75651, France
Unknown Facility
Berlin, 10969, Germany
Unknown Facility
Berlin, 13353, Germany
Unknown Facility
Frankfurt am Main, 60590, Germany
Unknown Facility
Hamburg, 20099, Germany
Unknown Facility
Hanover, 30625, Germany
Unknown Facility
Kiel, 24146, Germany
Unknown Facility
Leipzig, 04103, Germany
Unknown Facility
Grafton, 1010, New Zealand
Related Publications (1)
Tong X, Li L, Haines K, Najera I. Identification of the NS5B S282T resistant variant and two novel amino acid substitutions that affect replication capacity in hepatitis C virus-infected patients treated with mericitabine and danoprevir. Antimicrob Agents Chemother. 2014 Jun;58(6):3105-14. doi: 10.1128/AAC.02672-13. Epub 2014 Mar 17.
PMID: 24637689DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2011
First Posted
January 17, 2011
Study Start
February 1, 2011
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
November 2, 2016
Record last verified: 2016-11