Chronic Hepatitis C Clinical Trial
Official title:
A Randomized, Open Labeled, Active-Controlled Trial of 24-Week Versus 48-Week Courses of Peg-Interferon Alpha Plus Ribavirin for Genotype-1 Infected Chronic Hepatitis C Patients
The purposes of this study are:
1. To evaluate whether treatment with peginterferon and ribavirin for 24 weeks is
sufficient to achieve a sustained virological response (SVR) rate comparable to that
observed with the standard treatment duration of 48 weeks, in hepatitis C virus
genotype 1 (HCV-1) patients achieving a rapid virologic response (RVR; <50 IU/mL HCV
RNA at week 4) at 4 weeks.
2. To investigate the role of on-treatment virological responses among patients with 24 or
48 weeks treatment.
Peginterferon and ribavirin combination treatment has been recommended for all patients
infected with HCV, but the treatment duration varies depending on the HCV genotype.
Recommended treatment for patients with HCV-1 infection is pegylated interferon plus
ribavirin for 48 weeks and 24 weeks for HCV-2/3. A RVR is a strong predictor of SVR.
Previous studies have demonstrated that for HCV-2/3 patients who had a RVR, a shorter
duration of treatment with peginterferon plus standard dose of ribavirin over 14 weeks is as
effective as a 24-week treatment regimen. These findings have questioned whether shorter
treatment duration can yield high SVR rates for HCV-1 pts with an RVR.
The primary aim of the present study is to evaluate whether treatment with peginterferon and
ribavirin for 24 weeks is sufficient to achieve an SVR rate comparable to that observed with
the standard treatment duration of 48 weeks, in HCV-1 patients achieving an RVR at 4 weeks.
The secondary aim is to investigate the role of on-treatment virologic responses among
patients with 24 or 48 weeks treatment.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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