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

NCT ID: NCT00927290

Last Updated: 2017-01-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-03
• Study Completion Date: 2012-07-06

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 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.

Conditions

Chronic Hepatitis C; Insulin Resistance

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

1

Pioglitazone, 16 weeks before and during antiviral combination therapy

Group Type: ACTIVE_COMPARATOR

Pioglitazone

Intervention Type: DRUG

Pioglitazone, 45 mg QD (30 mg QD the first month)

2

Pioglitazone placebo, 16 weeks before and during antiviral combination therapy

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo 45 mg QD (30 mg QD the first month)

Interventions

Pioglitazone

Pioglitazone, 45 mg QD (30 mg QD the first month)

Intervention Type: DRUG

Placebo

Placebo 45 mg QD (30 mg QD the first month)

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

French National Agency for Research on AIDS and Viral Hepatitis

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vlad RATZIU, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Pitié--Salpêtrière, 83 Bd de l'Hôpital 75651 Paris cedex 13, FRANCE

Locations

Hôpital Pitié Salpêtrière, Service d'hépatogastroentérologie

Paris, , France

Countries

France

Other Identifiers

2008-006225-14

Identifier Type: -

Identifier Source: org_study_id