Pioglitazone vs. Placebo in Association With Pegylated Interferon and Ribavirin in HCV Patients With Insulin Resistance

• Status: Terminated
• Trial end date: 2012-07-06
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to test whether the correction of insulin resistance with pioglitazone, will improve the response to antiviral treatment.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: French National Agency for Research on AIDS and Viral Hepatitis
• Treatments: Antiviral Agents; Insulin; Interferons; Pioglitazone; Ribavirin

Criteria

Inclusion Criteria:

• 18 years old or older

• Chronic HCV infection documented by PCR with genotype HCV-1, 4, 5 or 6

• Naive Patient(never treated with antivirals for HCV)

• HOMA score higher than 2.5

• Patient for which the investigator decided to start antiviral treatment for chronic hepatitis C

Exclusion Criteria:

• Cardiovascular disease: heart failure stage NYHA II, III or IV, unstable angina, myocardial infarction in the previous year, cardiac surgery or stroke

• Alcohol consumption exceeding 40 g / day

• Decompensated liver disease: Child-Pugh B 8 or higher, or one of the following :

bilirubin over 35 mol / L, TP below 50%, ascites, encephalopathy

• Hepatocellular carcinoma or any other neoplasm (except if in remission for > 5 years)

• Other documented chronic liver disease

• Insulin treated diabetes

• HBV or HIV co-infection infection confirmed

• Thrombocytopenia below 50 000/mm ³; neutropenia below 750/mm ³ or hemoglobin below 11 g / dL

• Drug-induced steatosis(tamoxifen, glucocorticosteroids, amiodarone, tetracyclines).

• Bone marrow or solid organ transplantation

• Pregnancy or breastfeeding, or desire for pregnancy during the study period.

• Patients under legal protection or unable to express their consent