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

NCT00927290 | Terminated Phase 3 DMC

• 1 other identifier: 2008-006225-14
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Hepatitis C; Insulin Resistance

Keywords

hepatitis C; insulin resistance; glitazones; pioglitazone; steatosis; viral kinetics; antiviral response

Outcome Measures

Primary Outcomes (1)

• 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.

  W16

Secondary Outcomes (1)

• Kinetics of decrease in viral response to pegylated interferon. Early virological response rates. Rates of sustained virological response. Effect on steatosis

  EVR at W16 and W28 SVR at W88

Study Arms (2)

1

ACTIVE COMPARATOR

Pioglitazone, 16 weeks before and during antiviral combination therapy

Drug: Pioglitazone

2

PLACEBO COMPARATOR

Pioglitazone placebo, 16 weeks before and during antiviral combination therapy

Drug: Placebo

Interventions

Pioglitazone DRUG

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

1

Placebo DRUG

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

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• French National Agency for Research on AIDS and Viral Hepatitis: lead

Study Sites (1)

Hôpital Pitié Salpêtrière, Service d'hépatogastroentérologie

Paris, 75013, France

Location

MeSH Terms

Conditions

Hepatitis C, Chronic; Insulin Resistance; Hepatitis C; Fatty Liver

Interventions

Pioglitazone

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazolidinediones; Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Vlad RATZIU, MD, PHD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 22, 2009
• First Posted: June 24, 2009
• Study Start: December 3, 2009
• Primary Completion: July 6, 2012
• Study Completion: July 6, 2012
• Last Updated: January 24, 2017

Record last verified: 2017-01

Locations

FR (1)