drugset / Trial / NCT00122629

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

NCT00122629

RandomizedParallel-groupDouble-blindTreatment

Summary

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.

Timeline

Start
2000-10
Primary completion
Completion
2003-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Amantadine Unknown 200 mg
Background Peginterferon alfa-2b Protein / enzyme biologic 1.5 ug/kg
Background Ribavirin Small molecule 800 mg
Background Ribavirin Small molecule 1200 mg