Triple Therapy With Peg-Interferon Alfa-2b/Ribavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2b/Ribavirin for Previous Hepatitis C Virus (HCV) Non Responders
Triple antiviral therapy with peg-interferon-alfa/ribavirin+amantadine was suggested to increase sustained virological response (SVR) rates in HCV non-responders to a standard interferon/ribavirin combination.
Patients with hepatitis C virus infection were eligible if they had failed to respond to a single previous 24 week cycle of interferon/ribavirin combination therapy. Non-response was defined as persistent HCV RNA in the serum during the last month of treatment.
This study tested the efficacy and safety of pegylated interferon alfa-2b with ribavirin and amantadine or a placebo for 48 weeks.
|Hepatitis C, Chronic||Drug: peg-interferon alfa-2b Drug: ribavirin Drug: amantadine||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Triple Therapy With Peg-Interferon Alfa-2b/Ribavirin Plus Amantadine Compared to Standard Peg-Interferon Alfa-2b/Ribavirin for Previous HCV Non Responders ANRSHC03 BITRI|
- Sustained virological response, defined as an undetectable HCV-RNA 24 weeks after treatment discontinuation at week 72
- Biochemical response at week 72 defined as ALT normalization
- Histological benefit
- Virological and biochemical responses during therapy at weeks 12, 24 and 48
|Study Start Date:||October 2000|
|Estimated Study Completion Date:||May 2003|
Triple antiviral therapy with peg-interferon-alfa/ribavirin + amantadine was suggested to increase sustained virological response (SVR) rates in HCV non-responders to a standard interferon/ribavirin combination.
The aim of this study is to determine if the addition of amantadine to PEG-IFN/ribavirin enhances SVR.
This study is a double blind, comparative, prospective multicenter, randomized study. Patients are recruited from 23 hepatology centers in France. The protocol was approved by the French ethical committee and all patients provided written informed consent. Eligible subjects are randomly assigned to the two treatment groups in equal proportions. The randomization process is generated by the Department of Biostatistics, Hospices Civils de Lyon, Lyon, France.
Main inclusion criteria are: elevated ALT, detectable HCV RNA, Metavir score over or equal to A1F1 and below or equal to F3. Patients received PEG-IFN 1.5µg/kg/week, ribavirin 800-1200mg/day and amantadine 200mg/day or placebo during 48 weeks.
The primary endpoint is a sustained virological response, defined as an undetectable HCV-RNA 24 weeks after treatment discontinuation (week 72). Secondary endpoints are the biochemical response at week 72 defined as ALT normalization; histological benefit; tolerance; and virological and biochemical responses during therapy at weeks 12, 24 and 48.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00122629
|Service d’Hépato-Gastroentérologie Hopital Hotel Dieu|
|Lyon Cedex, France, 69288|
|Principal Investigator:||Christian Trepo, MD||Hépato-Gastroentérologie Hopital Hôtel-Dieu LYON|
|Study Chair:||P. ADELEINE, MD||Laboratoire d’Informatique Médicale Lyon|