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)
NCT ID: NCT01278134
Last Updated: 2016-11-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
170 participants
INTERVENTIONAL
2011-02-28
2012-10-31
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm B Extension
All patients in treatment arm B were offered to receive Pegasys/Cogepus therapy for an additional 24 weeks.
peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 24 weeks
ribavirin [Copegus]
1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
RO5024048 & ritonavir-boosted danoprevir without Ribavirin (B)
Copegus placebo
1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
RO5024048
1000 mg bid orally, up to 24 weeks
danoprevir
100 mg bid orally, up to 24 weeks
ritonavir
100 mg bid orally, up to 24 weeks
RO5024048 and ritonavir-boosted danoprevir with Ribavirin (A)
RO5024048
1000 mg bid orally, up to 24 weeks
danoprevir
100 mg bid orally, up to 24 weeks
ribavirin [Copegus]
1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
ritonavir
100 mg bid orally, up to 24 weeks
Interventions
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Copegus placebo
1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
RO5024048
1000 mg bid orally, up to 24 weeks
danoprevir
100 mg bid orally, up to 24 weeks
peginterferon alfa-2a [Pegasys]
180 mcg sc weekly, 24 weeks
ribavirin [Copegus]
1000 mg or 1200 mg daily orally in split doses (morning/evening), up to 24 weeks
ritonavir
100 mg bid orally, up to 24 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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La Jolla, California, United States
Sacramento, California, United States
Orlando, Florida, United States
Marietta, Georgia, United States
Honolulu, Hawaii, United States
Honolulu, Hawaii, United States
Chicago, Illinois, United States
Indianapolis, Indiana, United States
Lutherville, Maryland, United States
Detroit, Michigan, United States
Newark, New Jersey, United States
Albuquerque, New Mexico, United States
New York, New York, United States
Providence, Rhode Island, United States
Nashville, Tennessee, United States
Houston, Texas, United States
Newport News, Virginia, United States
Vancouver, Washington, United States
Clichy, , France
Créteil, , France
Lille, , France
Marseille, , France
Montpellier, , France
Paris, , France
Berlin, , Germany
Berlin, , Germany
Frankfurt am Main, , Germany
Hamburg, , Germany
Hanover, , Germany
Kiel, , Germany
Leipzig, , Germany
Grafton, , New Zealand
Countries
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References
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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.
Other Identifiers
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2010-022067-35
Identifier Type: -
Identifier Source: secondary_id
PP25213
Identifier Type: -
Identifier Source: org_study_id