Trial information
A Study of HCV Polymerase Inhibitor Pro-Drug in Combination With PEGASYS With or Without COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection.
Status: Completed
Protocol number: PV18369
Sponsor: Hoffmann-La Roche
Company division: Pharmaceutical
Official Scientific Title: A randomized, double-blind study to evaluate the safety and tolerability of the HCV polymerase inhibitor pro-drug in combination with Pegasys, with or without Copegus, versus Pegasys plus Copegus, in treatment-naïve patients with chronic hepatitis C, genotype 1
Brief summary: 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. Target sample size is
107.
Study phase: II
Study type: Interventional; Treatment; Randomized; Double Blind; Active; Parallel; Safety study
Condition: Hepatitis C, Chronic
Intervention type: Drug
Intervention name: HCV polymerase inhibitor pro-drug
Primary outcome: 1. AEs and laboratory parameters. Time frame: Week 4, 8 and Week 72
Key secondary outcomes: 1. Plasma concentration of HCV polymerase inhibitor Time frame: Week 4 and 8
2. Antiviral activity Time frame: Week 4, 8 and Week 72
Inclusion criteria:
- 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.
Exclusion criteria:
- 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.
Gender: Males or Females
Age limits: Min: N/A (No limit) Max: N/A (No limit)
Accepts healthy volunteers: No
Trial registration date: 09/18/2006
Date last updated: 11/21/2008
Link to trial result
This trial was conducted at the following locations:
United States
- La Jolla, CA
- Long Beach, CA
- Sacramento, CA
- San Diego , CA
- San Francisco, CA
- Aurora, CO
- Gainesville, FL
- Sarasota , FL
- Chicago, IL
- Novi, MI
- Manhasset, NY
- New York, NY
- Chapel Hill, NC
- Santurce, PR
- Dallas, TX
- Fort Sam Houston, TX
- Richmond, VA
