Trial Information

Summary: A Study of Combination Therapy With PEGASYS (Peginterferon alfa-2a (40KD)) and Copegus (Ribavirin) in Patients With Chronic Hepatitis C Genotype 2 or 3 Who Do Not Achieve a Rapid Viral Response.

Status: Recruiting

Protocol Number: MV21371

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effects of 24 vs 48 weeks of combination therapy with PEGASYS (peginterferon alfa-2a 40KD) plus COPEGUS (Ribavirin) on sustained virological response in patients with chronic hepatitis C, genotype 2 or 3 who do not achieve a rapid viral response.

Brief Summary: This study will evaluate the efficacy and safety of PEGASYS + Copegus combination therapy given for 24 weeks versus 48 weeks in patients with chronic hepatitis C, genotype 2/3. Patients receiving PEGASYS (180 micrograms sc weekly) + Copegus (800-1200mg po daily) who do not achieve a rapid viral response at week 4 will enter the study between treatment week 6 and 8, and will receive study medication. Those who have an early virological response at week 12, and are still taking medication at week 24, will then be randomized to one of 2 study groups. Group 1 will stop treatment at this point and will have a 48 week post-treatment observation period, and Group 2 will stay on medication for a further 24 weeks, followed by a 24 week post-treatment observation period. The anticipated time on study treatment is 6-12 months, and the target sample size is 100-500 individuals. Target sample size is 400.

Study Phase: III

Study Design / Study Details:

• Purpose: Treatment
• Allocation: Randomized
• Masking: Open Label
• Control: Active
• Assignment: Parallel
• Endpoints: Safety/Efficacy

Study Type:

Condition: Hepatitis C, Chronic

Intervention Type: Drug

Intervention Name: peginterferon alfa-2a (40KD) [PEGASYS]

Primary Outcome: 1. SVR Time frame: 24 weeks post-treatment (week 48 for Group 1, and week 72 for Group 2).

Key Secondary Outcomes: 1. Percentage of patients with non-detectable HCV-RNA Time frame: End of treatment (week 24 for Group 1 and week 48 for Group 2) 2. Percentage of patients with >=2 log10 drop in HCV-RNA Time frame: Treatment week 12 3. AEs, laboratory parameters. Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 02/15/2008

Date Last Updated: 08/18/2008

Link To Trial Results

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Trial listings updated: August 20, 2008 at 2:23:36 PM