Pioglitazone Versus Placebo in Association With Pegylated Interferon and Ribavirin in Hepatitis C Virus (HCV) Patients With Insulin Resistance
Information source: French National Agency for Research on AIDS and Viral Hepatitis
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Chronic Hepatitis C; Insulin Resistance
Intervention: Pioglitazone (Drug); Placebo (Drug)
Phase: Phase 3
Status: Not yet recruiting
Sponsored by: French National Agency for Research on AIDS and Viral Hepatitis Official(s) and/or principal investigator(s):
Vlad RATZIU, MD, PHD, Principal Investigator, Affiliation: Hôpital Pitié--Salpêtrière, 83 Bd de l'Hôpital 75651 Paris cedex 13, FRANCE
Overall contact:
Vlad RATZIU, MD, PHD, Phone: (33) 1 42 16 10 35, Email: vratziu@teaser.fr
Summary
The purpose of this study is to test whether the correction of insulin resistance with
pioglitazone, will improve the response to antiviral treatment.
Clinical Details
Official title: ANRS HC 22, PEGLIST-C, Multicenter, Randomized Controlled Trial of Pioglitazone vs. Placebo in Association With Pegylated Interferon and Ribavirin in Patients With Chronic Hepatitis C, Non 2 or 3 Genotypes and Insulin Resistance
Study design: Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Primary outcome: Decrease in the HOMA score below 2 after 4 months of treatment with pioglitazone or placebo(at W16). The efficiency is defined as a higher proportion of subjects with HOMA <2 in the pioglitazone group than in the group treated with placebo pioglitazone
Secondary outcome: Kinetics of decrease in viral response to pegylated interferon. Early virological response rates. Rates of sustained virological response. Effect on steatosis
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 search for strategies optimizing the results of antiviral therapy. Some
factors associated with non response have been identified. Among the modifiable factors,
numerous series have shown that insulin resistance adversely impacts the rate of sustained
virological response. The aim of this study is to determine whether the pharmacological
correction of insulin resistance through therapy with glitazones restores higher rates of
viral eradication and to determine the impact on the kinetics of viral response. Patients
will be randomized to receive pioglitazone or placebo starting 4 months before initiating
pegylated interferon and ribavirin and continued throughout the whole antiviral treatment
period.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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, gluco-corticosteroids, 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
Locations and Contacts
Vlad RATZIU, MD, PHD, Phone: (33) 1 42 16 10 35, Email: vratziu@teaser.fr
Hôpital Pitié Salpêtrière, Service d'hépatogastroentérologie, PARIS 75013, France
Additional Information
Starting date: July 2009
Ending date: June 2013
Last updated: September 10, 2009
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