NCT00545233

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.

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 155 (actual)
• Sponsor: Hoffmann-La Roche · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 1000-1600 mg/day (according to body weight) for 48 weeks or b)16 weeks of pioglitazone (30 mg daily for 8 weeks, then 45 mg daily for 8 weeks), followed by PEGASYS 180 micrograms/week + Copegus 1000-1600 mg/day + pioglitazone 45 mg daily for 48 weeks. The anticipated time on study treatment is 1-2 years, and the target sample size is 100-500 individuals.

Conditions

• Hepatitis C, Chronic

Interventions

Type	Name	Description
DRUG	peginterferon alfa-2a [Pegasys]	180 micrograms subcutaneous weekly for 48 weeks
DRUG	ribavirin [Copegus]	1000-1600 mg day orally for 48 weeks.
DRUG	Pioglitazone	30 mg daily for 8 weeks increasing to 45 mg daily for 64 weeks.

Timeline

• Start date: 2008-01-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2007-10-17
• Last updated: 2012-05-07
• Results posted: 2012-05-07

Locations

66 sites across 2 countries: United States, Puerto Rico