drugset / Trial / NCT00299923

Study for Patients With Chronic HCV (GT 1 or 3) Who Relapsed to Previous (Peg)Interferon/ Ribavirin Combination Therapy

NCT00299923

RandomizedParallel-groupOpen-labelTreatment

Summary

The aim of this study is, to compare the relapse rate in chronic HCV patients with genotype 1 or 3 under the combination of standard dose Peg-Interferon alfa-2a (PEG-IFN alfa-2a), Ribavirin (RBV) and Amantadine (AMA) given for 72 weeks (group A), versus the same combination, given for 48 weeks (group B) in patients who relapsed to previous combination therapy to conventional or pegylated (PEG) Interferon alfa and Ribavirin. Relapse ist defined as percentage of patients with non-detectable HCV-RNA at end of therapy (week 48 GT1/ week 24 GT 3) who become HCV-RNA positive during a follow-up period of 24 weeks.

Timeline

Start
2005-11
Primary completion
Completion

Drugs

EvaluationDrugModalityDoseRoute
Subject Amantadine Unknown
Subject Peginterferon alfa-2a Protein / enzyme biologic
Subject Ribavirin Small molecule