Overview

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

Status:
Unknown status

Trial end date:
2014-12-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 4

Details

Lead Sponsor:

Chang Gung Memorial Hospital

Collaborator:

Merck Sharp & Dohme Corp.

Treatments:

Interferon-alpha
Peginterferon alfa-2b
Ribavirin