drugset / Trial / NCT01683786

36 vs 48 Wks Peg-Intron Plus Ribavirin for HCV Patients Without Rapid Virologic Response But Without HCV RNA at wk 8

NCT01683786

RandomizedParallel-groupOpen-labelTreatment

Summary

Purpose: To compare the effectiveness of 36 weeks versus 48 weeks pegintron plus ribavirin treatment for hepatitis C virus(HCV) patients without rapid virologic response(RVR), but with undetectable HCV RNA at wk 8. Study Design: a multi-site, prospective, open label, randomized, pilot trial. Approximately 60 HCV Genotype 1 patients who fail to achieve RVR but achieve undetectable HCV RNA at week 8 (\<50 IU/ml) will be recruited into 2 arms(30 in each arm). Patients must receive pegylated interferon-α2b at 1.5 μg/kg of body weight/week and ribavirin 800\~1400 mg/day for 12 wks before entering this study.

Timeline

Start
2011-08
Primary completion
2014-12
Completion
2014-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Peginterferon alfa-2b Protein / enzyme biologic 1.5 ug/kg
Subject Ribavirin Small molecule 800 mg
Subject Ribavirin Small molecule 1400 mg