Status:
TERMINATED
Pioglitazone vs. Placebo in Association With Pegylated Interferon and Ribavirin in HCV Patients With Insulin Resistance
Lead Sponsor:
French National Agency for Research on AIDS and Viral Hepatitis
Conditions:
Chronic Hepatitis C
Insulin Resistance
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to test whether the correction of insulin resistance with pioglitazone, will improve the response to antiviral treatment.
Detailed Description
In patients infected with genotypes 1, 4, 5 and 6, the response rate to antiviral therapy remains suboptimal (less than one in two patients have a sustained virological response), which justifies the ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 3 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 6 2012
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00927290
Start Date
December 3 2009
End Date
July 6 2012
Last Update
January 24 2017
Active Locations (1)
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1
Hôpital Pitié Salpêtrière, Service d'hépatogastroentérologie
Paris, France, 75013