A Study of Daclatasvir and Sofosbuvir With Ribavirin in Subjects With Cirrhosis and Genotype 3 Hepatitis C Infection

• Status: Completed
• Trial end date: 2017-05-26
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine whether 24 weeks of Daclatasvir and Sofosbuvir with Ribavirin is safe and effective in the treatment of genotype 3 hepatitis C infected patients with liver cirrhosis.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

For more information regarding Bristol-Myers Squibb (BMS) Clinical Trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

• Genotype 3 HCV

• HCV RNA ≥10000 IU (International Unit)/mL

• Compensated Liver Cirrhosis

• BMI 18-40 kg/m2

• Previously treated for HCV or never treated for HCV

Exclusion Criteria:

• Infection with HCV other than Genotype 3. Mixed infection of any genotype

• Evidence of decompensated liver disease

• Previous exposure to NS5A inhibitors

Other protocol defined inclusion/exclusion criteria could apply