Trial Information

Summary: A Study of PEGASYS (Peginterferon alfa-2a (40KD)) Plus COPEGUS (Ribavirin) With or Without Pioglitazone in Treatment-Naive Patients With Chronic Hepatitis C and Insulin Resistance.

Status: Recruiting

Protocol Number: ML21301

Sponsor: Hoffmann-La Roche

Company Division: Pharmaceutical

Official Scientific Title: A randomized, open-label study of the effect of PEGASYS ® plus COPEGUS® with or without concomitant pioglitazone (Actos®) on early viral kinetics in treatment-naive patients with chronic hepatitis C, genotype-1, and insulin resistance

Brief Summary: This 2 arm study will assess the efficacy and safety of PEGASYS plus COPEGUS, with or without concomitant pioglitazone, on hepatitis C virus titers in treatment-naive patients with genotype 1 chronic hepatitis C, and insulin resistance. Patients will be randomized to receive either a)PEGASYS 180 micrograms/week + Copegus 1000-1600mg/day (according to body weight) or b)16 weeks of pioglitazone (30mg daily for 8 weeks, then 45mg daily for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600mg/day + pioglitazone 45mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals. Target sample size is 240.

Study Phase: IV

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. Change in HCV RNA Time frame: Week 12 of anti-HCV treatment

Key Secondary Outcomes: 1. Percentage of patients with undetectable HCV RNA, percentage of patients with >2log10 decrease in HCV RNA, change in log10 HCV RNA. Time frame: Week 12 2. Glycemic and lipid control, and insulin resistance. Time frame: At intervals throughout study 3. AEs, laboratory parameters, beta-type natriuretic peptide Time frame: Throughout study

Inclusion Criteria:

Exclusion Criteria:

Gender: Males or Females

Age Limits: Min: 18 Years

Accepts Healthy Volunteers: No

Anticipated Start Date: November, 2007

Trial Registration Date: 10/15/2007

Date Last Updated: 08/18/2008

Link To Trial Results

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Trial listings updated: September 2, 2008 at 2:13:14 PM