Trial Information

Summary: 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 Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Double Blind
• Control: Active
• Assignment: Parallel
• Endpoints: Safety

Study Type:

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:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 65 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: September, 2006

Trial Registration Date: 09/18/2006

Date Last Updated: 08/18/2008

Link To Trial Results

This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.

Trial listings updated: August 20, 2008 at 2:20:33 PM