Hepatitis C Clinical Trial
Official title:
A Randomized, Multicenter, Open Label Study Evaluating the Efficacy and Safety of Tailored Regimens With Peginterferon Alfa-2a Plus Ribavirin According Viral Kinetics for Genotype 1 Chronic Hepatitis C Patients
The purposes of this study are:
1. To test if 36 weeks of standard dose of ribavirin with PEGASYS® is non-inferior to
standard dose of 48 weeks of ribavirin with PEGASYS® in SVR for patients with RVR and
HVL
2. To test if the 72 weeks of treatment with PEGASYS® plus standard dose ribavirin is
superior to 48 weeks of the same treatment for patients with HCV RNA seropositivity at
week 12
The aims of the present study are:
1. To evaluate the efficacy and safety of 36-week versus 48-week regimen of PEGASYS®
(peginterferon alfa-2a, PegIFN) plus standard-dose of ribavirin (RBV) in hepatitis C
virus (HCV) genotype 1 infected, treatment-naïve CHC patients who have high viral loads
(HVL, defined as baseline HCV RNA ≧ 400,000 IU/mL) and achieve a rapid virologic
response (RVR) (defined as seronegativity of HCV RNA at week 4 of treatment)
2. To evaluate the efficacy and safety of 48-week versus 72-week regimen of PegIFN plus
standard-dose of RBV in HCV virus genotype 1 infected, treatment-naïve CHC patients
with PCR-seropositive of HCV RNA at week 12
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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