Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine for the Treatment of Hepatitis C Infected Patients (PEGARI)
|HCV Infection Hepatitis C, Chronic||Drug: Peginterferon alfa-2a Drug: ribavirin Drug: amantadine||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||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|
- 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 ]
- ALT < upper limit of normal values, [ Time Frame: 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 ]
- adverse effects
- quality of life assessed [ Time Frame: at week 72 ]
|Study Start Date:||November 2001|
|Study Completion Date:||April 2004|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00221624
|Service d’hépato-Gastro-Entérologie - Hôpital Haut Leveque - avenue de Magellan|
|Pessac, France, 33604|
|Principal Investigator:||Patrice Couzigou, Pr||University Hospital, Bordeaux|
|Study Chair:||Geneviève Chêne, Pr||University Hospital, Bordeaux|