At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 4 clinical trial evaluating pegylated interferon alpha 2a and ribavirin and Pegylated interferon alfa-2a and ribavirin for Chronic Hepatitis C and Genotype. Completed, enrolled 200 participants across 1 site.
Detailed Summary
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.
Study Details
Timeline
Interventions
pegylated interferon alpha 2a 180 mcg/week and ribavirin 1000-1200 mg/day for 48 weeks
Pegylated interferon alfa-2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks