Trial Information

Summary: A Study of HCV Polymerase Inhibitor Pro-Drug in Combination With PEGASYS Plus COPEGUS Compared With PEGASYS Plus COPEGUS in Patients With Chronic Hepatitis C Genotype 1 Infection.

Status: No longer recruiting

Protocol Number: NV19865

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, double-blinded study to evaluate the safety and effect on sustained virological response of HCV polymerase inhibitor pro-drug in combination with PEGASYS plus Copegus, compared with the currently approved combination of PEGASYS plus Copegus, in treatment-naïve patients with chronic he

Brief Summary: This 7 arm study will determine the optimal treatment combination, based on efficacy and safety. Patients with chronic hepatitis C (CHC), genotype 1, will be randomized to one of 7 treatment groups. Groups 1, 2, 4, 5 and 6 will receive triple combination treatment with HCV polymerase inhibitor pro-drug (at doses of 500, 1000 or 1500mg po bid) plus PEGASYS (90 or 180 micrograms sc weekly) plus Copegus (1000 or 1200mg po qd) for 24 weeks, followed by 24 weeks of open label Standard of Care (PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd). Group 3 will receive HCV polymerase inhibitor pro-drug 500mg po bid plus PEGASYS 180 micrograms sc weekly plus Copegus 1000/1200mg po qd for 24 weeks; after 24 weeks, those achieving a rapid virological response (RVR) will stop all medication, and non-RVR patients will remain on triple combination for an additional 24 weeks. Group 7 will receive SOC for 48 weeks. There will be a 24 week period of treatment-free follow-up for all treatment groups. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. Target sample size is 490.

Study Phase: II

Study Design / Study Details:

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

Study Type:

Condition: Hepatitis C, Chronic

Intervention Type: Drug

Intervention Name: HCV polymerase inhibitor pro-drug

Primary Outcome: 1. Sustained virological response (SVR) Time frame: 24 weeks post treatment end (ie weeks 48 or 72)

Key Secondary Outcomes: 1. Virological response over time Time frame: Throughout study 2. SVR Time frame: 12 weeks post treatment end (ie weeks 36 or 60) 3. Relapse rate Time frame: End of treatment (ie weeks 24 or 48) 4. AEs, laboratory parameters. Time frame: Throughout treatment

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years Max: 65 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: December, 2007

Trial Registration Date: 08/15/2007

Date Last Updated: 04/16/2008

Link To Trial Results

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Trial listings updated: May 13, 2008 at 1:58:55 PM