Official 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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: peginterferon alfa-2a (40KD) [PEGASYS]
  • 180 micrograms sc weekly for 48 weeks
• Drug: Copegus
  • 1000-1600mg po / day for 48 weeks
• Drug: Pioglitazone
  • 30mg increasing to 45mg daily for 64 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• Change in HCV RNA
  • Time Frame: Week 12 of anti-HCV treatment
    Safety Issue?: No

Secondary Measures

• 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
    Safety Issue?: No
• Glycemic and lipid control, and insulin resistance.
  • Time Frame: At intervals throughout study
    Safety Issue?: No
• AEs, laboratory parameters, beta-type natriuretic peptide
  • Time Frame: Throughout study
    Safety Issue?: No

Inclusion Criteria:

• adult patients, >=18 years of age;
• chronic hepatitis C, genotype 1;
• insulin resistance.

Exclusion Criteria:

• other forms of liver disease;
• cirrhosis;
• previous treatment for chronic hepatitis C;
• insulin treatment during prior 2 weeks;
• type 1 diabetes.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Hoffmann-La Roche

Overall Clinical Trial Officials and Contacts

Clinical Trials Study Director Hoffmann-La Roche, +1 973 235 5000  

Overall Contact: Please reference Study ID Number: ML21301 973-235-5000 

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00545233

Study ID Number: ML21301

ClinicalTrials.gov Identifier: NCT00545233

Health Authority: United States: Food and Drug Administration