Pioglitazone Versus Placebo in Association With Pegylated Interferon and Ribavirin in Hepatitis C Virus (HCV) Patients With Insulin Resistance - Full Text View

Sponsor:	French National Agency for Research on AIDS and Viral Hepatitis
Information provided by:	French National Agency for Research on AIDS and Viral Hepatitis
ClinicalTrials.gov Identifier:	NCT00927290

Purpose

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

Condition	Intervention	Phase
Chronic Hepatitis C Insulin Resistance	Drug: Pioglitazone Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
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

Resource links provided by NLM:

MedlinePlus related topics: Hepatitis Hepatitis C

Drug Information available for: Insulin Ribavirin Pioglitazone Pioglitazone hydrochloride Interferons

U.S. FDA Resources

Further study details as provided by French National Agency for Research on AIDS and Viral Hepatitis:

Primary Outcome Measures:

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 [ Time Frame: W16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Kinetics of decrease in viral response to pegylated interferon. Early virological response rates. Rates of sustained virological response. Effect on steatosis [ Time Frame: EVR at W16 and W28 SVR at W88 ] [ Designated as safety issue: No ]

Estimated Enrollment:	90
Study Start Date:	July 2009
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Active Comparator Pioglitazone, 16 weeks before and during antiviral combination therapy	Drug: Pioglitazone Pioglitazone, 45 mg QD (30 mg QD the first month)
2: Placebo Comparator Pioglitazone placebo, 16 weeks before and during antiviral combination therapy	Drug: Placebo Placebo 45 mg QD (30 mg QD the first month)

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

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00927290

Contacts

Contact: Vlad RATZIU, MD, PHD	(33) 1 42 16 10 35	vratziu@teaser.fr
Contact: Delphine FROMENTIN, Pharm.D	(33) 1 44 73 89 51	delphine.fromentin@u707.jussieu.fr

Locations

France
Hôpital Pitié Salpêtrière, Service d'hépatogastroentérologie
PARIS, France, 75013

Sponsors and Collaborators

French National Agency for Research on AIDS and Viral Hepatitis

Investigators

Principal Investigator:

Vlad RATZIU, MD, PHD

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

More Information

No publications provided

Responsible Party:	ANRS ( Karim KAABECHE/Regulatory affairs )
Study ID Numbers:	2008-006225-14
Study First Received:	June 22, 2009
Last Updated:	September 10, 2009
ClinicalTrials.gov Identifier:	NCT00927290 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Keywords provided by French National Agency for Research on AIDS and Viral Hepatitis:

hepatitis C
insulin resistance
glitazones
pioglitazone

steatosis
viral kinetics
antiviral response

Additional relevant MeSH terms:

Liver Diseases
RNA Virus Infections
Metabolic Diseases
Pioglitazone
Hepatitis, Chronic
Flaviviridae Infections
Physiological Effects of Drugs
Hepatitis, Viral, Human
Pharmacologic Actions
Insulin

Hepatitis
Virus Diseases
Hyperinsulinism
Hypoglycemic Agents
Digestive System Diseases
Hepatitis C
Insulin Resistance
Glucose Metabolism Disorders
Hepatitis C, Chronic

ClinicalTrials.gov processed this record on February 08, 2010