CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 308 enrolled
Drug / intervention
Pegylated interferon alfa-2a plus ribavirin +1 moredrug
Likely dose
Pegylated interferon alfa-2a plus ribavirin 1200 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00495131
NCT00495131Phase 4Completed

Randomized Trial of 24 or 48 Weeks of Peginterferon Alfa-2a Plus Ribavirin for Chronic Hepatitis C Virus Genotype 1-infected Patients in Taiwan

National Taiwan University Hospital·interventional·Posted Jul 2, 2007·Updated Sep 10, 2009

In Brief

A Phase 4 clinical trial evaluating Pegylated interferon alfa-2a plus ribavirin for Hepatitis C, Chronic. Completed, enrolled 308 participants across 6 sites.

Detailed Summary

Chronic hepatitis C virus (HCV) infection is prevalent in the world, affecting 3% of the world's population. The current standard of therapy is pegylated interferon and ribavirin, reaching 54-63% of successful rates. In patients with HCV genotype 1 infection, a 48 week course of combination therapy has achieved a higher successful rate that a 24 weeks course of therapy. However, several studies in Taiwan have shown that a 24 week course of therapy has comparable or even better response to a 48 week course of therapy in Western countries. Therefore, whether a 48 week course of therapy can achieve a higher response to a 24 week course of therapy in Taiwanese patients with genotype 1 HCV infection remains unclear.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesTaiwan

Timeline

Phase 4CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 2, 2007
Enrollment StartJun 1, 2006
Primary CompletionJun 1, 2008
Study CompletionJul 1, 2008
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 19 years ago

Interventions

Pegylated interferon alfa-2a plus ribavirindrug

Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 24 weeks

Pegylated interferon alfa-2a plus ribavirindrug

Pegylated interferon alfa-2a (Pegasys, F. Hoffmann-LaRoche) 180 ug/week plus ribavirin (Robatrol, F. Hoffmann-LaRoche) 1000-1200 mg/day (\<75 kg, 1000 mg/day; \>= 75 kg, 1200 mg/day) for 48 weeks