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.

Completed · Phase 4

Conditions studied: Hepatitis C, Chronic

In brief

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.

Key facts

Study ID

NCT00545233

Run by

Hoffmann-La Roche

People needed

155

Starts

2008-01-01

Expected to finish

2010-12-01

Last updated by the study team

2012-05-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

• Study site — Tucson, Arizona, United States
• Study site — Anaheim, California, United States
• Study site — Fresno, California, United States
• Study site — La Jolla, California, United States
• Study site — Loma Linda, California, United States
• Study site — Los Angeles, California, United States
• Study site — Merced, California, United States
• Study site — Palo Alto, California, United States
• Study site — Pasadena, California, United States
• Study site — San Clemente, California, United States
• Study site — San Mateo, California, United States
• Study site — Englewood, Colorado, United States
• Study site — Littleton, Colorado, United States
• Study site — Hartford, Connecticut, United States
• Study site — Atlanta, Georgia, United States
• Study site — Chicago, Illinois, United States
• Study site — Downers Grove, Illinois, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Indianapolis, Indiana, United States
• Study site — Iowa City, Iowa, United States
• Study site — Louisville, Kentucky, United States
• Study site — New Orleans, Louisiana, United States
• Study site — Portland, Maine, United States
• Study site — Baltimore, Maryland, United States
• Study site — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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