A Study of Hepatitis C Virus (HCV) Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C (CHC) Genotype 1 Infection.

Completed · Phase 2

Conditions studied: Hepatitis C, Chronic

In brief

This 4 arm study will compare the safety and tolerability of HCV polymerase inhibitor pro-drug in combination with PEGASYS +/- COPEGUS with the standard of care therapy of PEGASYS + COPEGUS, in treatment-naive patients with CHC, genotype 1. Patients will be randomized to receive 1500mg or 3000mg po bid of HCV polymerase inhibitor pro-drug + PEGASYS, 1500mg of HCV polymerase inhibitor pro-drug + PEGASYS + COPEGUS or PEGASYS + COPEGUS for 4 weeks. All patients who receive at least one dose of study medication will receive open label PEGASYS + Copegus for an additional 44 weeks after the 4 week experimental period. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.

Key facts

Study ID

NCT00377182

Run by

Hoffmann-La Roche

People needed

107

Starts

2006-09-01

Expected to finish

2008-08-01

Last updated by the study team

2016-11-02

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• adult patients, 18-65 years of age;
• CHC without liver cirrhosis or incomplete/transition to liver cirrhosis, genotype 1;
• chronic liver disease consistent with CHC.

You may not qualify if…

• infection with any HCV genotype other than genotype 1;
• previous treatment for CHC;
• medical condition associated with chronic liver disease other than CHC;
• HIV, Hepatitis A, Hepatitis B infection.

Where it is running

• Study site — La Jolla, California, United States
• Study site — Long Beach, California, United States
• Study site — Sacramento, California, United States
• Study site — San Diego, California, United States
• Study site — San Diego, California, United States
• Study site — San Francisco, California, United States
• Study site — Aurora, Colorado, United States
• Study site — Bradenton, Florida, United States
• Study site — Gainesville, Florida, United States
• Study site — Chicago, Illinois, United States
• Study site — Novi, Michigan, United States
• Study site — Manhasset, New York, United States
• Study site — New York, New York, United States
• Study site — Chapel Hill, North Carolina, United States
• Study site — Dallas, Texas, United States
• Study site — Fort Sam Houston, Texas, United States
• Study site — Richmond, Virginia, United States
• Study site — Santurce, Puerto Rico

Full record on ClinicalTrials.gov

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