A Study of RO5024048 in Combination With Pegasys (Peginterferon Alfa-2a) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 1 or 4

Completed · Phase 2

Conditions studied: Hepatitis C, Chronic

In brief

This equally randomized (1:1), double-blind, parallel arm study will assess the safety and antiviral efficacy of RO5024048 added to standard Pegasys (peginterferon alfa-2a) plus Copegus (ribavirin) therapy in patients with chronic hepatitis C genotype 1 or 4. Patients in arm A will receive RO5024048 (1000mg orally twice daily) for 24 weeks in addition to Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily). Patients achieving a rapid virological response (RVR) at week 4, sustained through week 22, will stop all treatment at week 24; non-RVR patients will continue treatment with Pegasys and Copegus for another 24 weeks up to week 48. Patients in arm B will receive standard treatment with Pegasys (180 micrograms sc weekly) and Copegus (1000mg or 1200mg orally daily) for 48 weeks. Anticipated time on study treatment is up to 48 weeks. Target sample size is \<200.

Key facts

Study ID

NCT01057667

Run by

Hoffmann-La Roche

People needed

168

Starts

2010-02-01

Expected to finish

2012-04-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients, 18-70 years of age
• hepatitis C, genotype 1 or 4, of over 6 months duration
• treatment-naïve
• negative pregnancy test; female patients of childbearing age and male patients with female partners of childbearing age must use two forms of contraception during treatment and following the last dose of ribavirin in accordance with locally approved label for ribavirin

You may not qualify if…

• pregnant or breast feeding females or male partners of pregnant females
• previous interferon or ribavirin based therapy or investigational anti-HCV agent
• systemic antiviral therapy with established or perceived activity against HCV </=3 months prior to first dose of study drug
• hepatitis A or B, or HIV infection
• history or evidence of medical condition associated with chronic liver disease other than HCV

Where it is running

• Study site — La Jolla, California, United States
• Study site — Bradenton, Florida, United States
• Study site — Atlanta, 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 — Kansas City, Kansas, United States
• Study site — Kansas City, Missouri, United States
• Study site — Lebanon, New Hampshire, United States
• Study site — Albuquerque, New Mexico, United States
• Study site — New York, New York, United States
• Study site — New York, New York, United States
• Study site — The Bronx, New York, United States
• Study site — Philadelphia, Pennsylvania, United States
• Study site — Columbia, South Carolina, United States
• Study site — Nashville, Tennessee, United States
• Study site — Houston, Texas, United States
• Study site — San Antonio, Texas, United States
• Study site — Calgary, Alberta, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Vancouver, British Columbia, Canada
• Study site — Winnipeg, Manitoba, Canada
• Study site — London, Ontario, Canada
• Study site — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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