Hepatitis C, Chronic Clinical Trial
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
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