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Pioglitazone vs. Placebo in Association With Pegylated Interferon and Ribavirin in HCV Patients With Insulin Resistance (PEGLIST C)

Primary Purpose

Chronic Hepatitis C, Insulin Resistance

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Pioglitazone
Placebo
Sponsored by
French National Agency for Research on AIDS and Viral Hepatitis
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Hepatitis C focused on measuring hepatitis C; insulin resistance; glitazones; pioglitazone; steatosis; viral kinetics; antiviral response

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital Pitié Salpêtrière, Service d'hépatogastroentérologie

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

1

2

Arm Description

Pioglitazone, 16 weeks before and during antiviral combination therapy

Pioglitazone placebo, 16 weeks before and during antiviral combination therapy

Outcomes

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 22, 2009
Last Updated
January 23, 2017
Sponsor
French National Agency for Research on AIDS and Viral Hepatitis
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1. Study Identification

Unique Protocol Identification Number
NCT00927290
Brief Title
Pioglitazone vs. Placebo in Association With Pegylated Interferon and Ribavirin in HCV Patients With Insulin Resistance
Acronym
PEGLIST C
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 Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Terminated
Why Stopped
Suspension of use of medicine containing Pioglitazone by French regulatory agency
Study Start Date
December 3, 2009 (Actual)
Primary Completion Date
July 6, 2012 (Actual)
Study Completion Date
July 6, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
French National Agency for Research on AIDS and Viral Hepatitis

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hepatitis C, Insulin Resistance
Keywords
hepatitis C; insulin resistance; glitazones; pioglitazone; steatosis; viral kinetics; antiviral response

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Pioglitazone, 16 weeks before and during antiviral combination therapy
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Pioglitazone placebo, 16 weeks before and during antiviral combination therapy
Intervention Type
Drug
Intervention Name(s)
Pioglitazone
Intervention Description
Pioglitazone, 45 mg QD (30 mg QD the first month)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 45 mg QD (30 mg QD the first month)
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vlad RATZIU, MD, PHD
Organizational Affiliation
Hôpital Pitié--Salpêtrière, 83 Bd de l'Hôpital 75651 Paris cedex 13, FRANCE
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Pitié Salpêtrière, Service d'hépatogastroentérologie
City
Paris
ZIP/Postal Code
75013
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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