Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine for the Treatment of Hepatitis C Infected Patients (PEGARI)

June 12, 2007 updated by: University Hospital, Bordeaux

Randomized Placebo-Controlled Trial of a Triple Therapy Combining Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine Versus Peginterferon Alfa-2a Plus Ribavirin Plus Placebo in Hepatitis C-Infected Patients Non Responders to a First-Line Therapy of Interferon and Ribavirin

Response to a second-line anti-HCV treatment in non responder patients to a first-line dual therapy remains very poor. Preliminary studies of amantadine suggest that this drug could be potentially effective to treat hepatitis C.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background : Response to a second-line anti-HCV treatment in non responder patients to a first-line dual therapy remains very poor. Preliminary studies of amantadine suggest that this drug could be potentially effective to treat hepatitis C.

Design : randomized, double-blind, multicenter trial.

Interventions compared : Peg-interferon alfa 2A + ribavirin + amantadine versus Peg-interferon alfa 2A + ribavirin + Placebo

Eligibility criteria : Chronic hepatitis C, previously treated with combination of interferon plus ribavirin for at least 24 weeks,detectable HCV RNA.

primary outcome : sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti HCV treatment.

Study Type

Interventional

Enrollment (Actual)

131

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Pessac, France, 33604
    - Service d'hépato-Gastro-Entérologie - Hôpital Haut Leveque - avenue de Magellan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Chronic hepatitis C
Previously treated with a combination of interferon plus ribavirin for at least 24 weeks
Detectable HCV RNA (i.e. non responders)
Signed informed consent

Exclusion Criteria:

Evidence of another cause of liver disease
Liver cirrhosis (child-Pugh stage BMC)
Alcohol consumption > 30g/day for women or > 40g/day for men ; drug abuse
Other serious relevant disorders : psychiatric condition (especially depression), cardio-vascular disease, renal decompensation, seizure history, hemoglobinopathy, auto-immune disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: Double

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
sustained virological response, defined as an undetectable HCV RNA level 24 weeks after the end of anti HCV treatment (i.e. overall 72 weeks after randomization) Time Frame: 24 weeks after the end of antiHCV treatment	24 weeks after the end of antiHCV treatment

Secondary Outcome Measures

Outcome Measure	Time Frame
adverse effects
ALT < upper limit of normal values, Time Frame: 24 weeks after the end of anti-HCV treatment	24 weeks after the end of anti-HCV treatment
histological response according to METAVIR score Time Frame: 24 weeks after the end of anti-HCV treatment	24 weeks after the end of anti-HCV treatment
quality of life assessed Time Frame: at week 72	at week 72

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

Collaborators

Hoffmann-La Roche

Investigators

Study Chair: Geneviève CHENE, Pr, University Hospital, Bordeaux
Principal Investigator: Patrice Couzigou, Pr, University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2001

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria