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.

Roche

Status and phase: Completed; Phase 4

Conditions: Hepatitis C, Chronic

Treatments: Drug: peginterferon alfa-2a [Pegasys]; Drug: ribavirin [Copegus]; Drug: Pioglitazone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00545233

ML21301

Details and patient eligibility

About

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.

Enrollment: 155 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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155 participants in 2 patient groups

PEG-INF alpha-2a + ribavirin+ pioglitazone

Experimental group

Description:

Participants received pioglitazone in a 16 week run-in period (30 mg per day orally for 8 weeks followed by 45 mg per day orally for 8 weeks). Participants then received piogliatzone 45 mg daily orally plus 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a) subcutaneous (sc) once a week plus ribavirin (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase. Participants received 45 mg of pioglitazone per day orally in the 24 week follow-up period.

Treatment:

Drug: Pioglitazone

Drug: ribavirin [Copegus]

Drug: peginterferon alfa-2a [Pegasys]

PEG-INF alpha-2a + ribavirin

Active Comparator group

Description:

Participants received 18 μg of Peginterferon Alfa-2a (PEG-INF alpha-2a) subcutaneous (sc) once a week plus ribavirin (1000 - 1600 mg/day orally as a split dose in the morning and the evening based on the participant's body weight) for 48 weeks in the anti-HCV treatment phase followed by a treatment free 24 week follow-up period.

Treatment:

Drug: ribavirin [Copegus]

Drug: peginterferon alfa-2a [Pegasys]