Peginterferon Alfa-2a Plus Ribavirin Plus Amantadine for the Treatment of Hepatitis C Infected Patients (PEGARI)
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|ClinicalTrials.gov Identifier: NCT00221624|
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : June 13, 2007
|Condition or disease||Intervention/treatment||Phase|
|HCV Infection Hepatitis C, Chronic||Drug: Peginterferon alfa-2a Drug: ribavirin Drug: amantadine||Phase 3|
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 (Clinical Trial)|
|Actual Enrollment :||131 participants|
|Intervention Model:||Parallel Assignment|
|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|
|Study Start Date :||November 2001|
|Actual Study Completion Date :||April 2004|
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|