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)

Completed · Phase 2 · Has a placebo group

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT01278134

Run by

Hoffmann-La Roche

People needed

170

Starts

2011-02-01

Expected to finish

2012-10-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Study site — La Jolla, California, United States
• Study site — Sacramento, California, United States
• Study site — Orlando, Florida, United States
• Study site — Marietta, Georgia, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Honolulu, Hawaii, United States
• Study site — Chicago, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Lutherville, Maryland, United States
• Study site — Detroit, Michigan, United States
• Study site — Newark, New Jersey, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — New York, New York, United States
• Study site — Providence, Rhode Island, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — Newport News, Virginia, United States
• Study site — Vancouver, Washington, United States
• Study site — Clichy, France
• Study site — Créteil, France
• Study site — Lille, France
• Study site — Marseille, France
• Study site — Montpellier, France
• Study site — Paris, France
• Study site — Berlin, Germany

Full record on ClinicalTrials.gov

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