A Randomized, Open-Label Study of Daclatasvir and Sofosbuvir With or Without Ribavirin for 8 Weeks in Treatment-Naïve, Non-cirrhotic Subjects Infected With Chronic Hepatitis C Virus (HCV) Genotype 3

• Status: Withdrawn
• Trial end date: 2017-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if 8 weeks of Daclatasvir plus Sofosbuvir with or without Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients without advanced fibrosis or liver cirrhosis who have never been treated previously.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bristol-Myers Squibb
• Treatments: Ribavirin; Sofosbuvir

Criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Genotype 3

• HCV RNA < 2000000 IU/mL

• Never taken HCV medication

• Absence of advanced fibrosis or cirrhosis

• Body mass index (BMI) 18-40 kg/m^2

Exclusion Criteria:

• Infection with HCV other than genotype 3 (GT3); Mixed infections of any genotype

• Previously taken HCV medication

• Liver Cirrhosis

• Evidence of decompensated liver disease

• HIV/ hepatitis B virus (HBV) coinfection