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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, Germany
Universitätsklinikum Mannheim
Mannheim, Baden-Würtemberg, Germany
Universitätsklinikum Heidelberg
Heidelberg, Baden-Württembeg, Germany
Universitätsklinikum Erlangen
Erlangen, Bavaria, Germany
- Comparison of the rate of relapse under the combination of standard dose PegIFN alfa-2a, Ribavirin and Amantadine given for 72 vs. 48 weeks.
relationship between EVR during the first twelve weeks and SVR
virological response to the combination of standard dose defined as reduction of HCV RNA at week 4, 12, 24, 48 and 72 of treatment, separated between HCV-Genotypes.
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Klinikum rechts der Isar der TU München
München, Bavaria, Germany
Krankenhaus Barmherzige Brüder
Regensburg, Bavaria, Germany
Klinikum der Universität Regensburg
Regensburg, Bavaria, Germany
Klinikum der Universität Würzburg
Würzburg, Bavaria, Germany
Klinikum Bremen-Mitte
Bremen, City state Bremen, Germany
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