Short Duration Combination Therapy With Daclatasvir, Asunaprevir, BMS-791325 and Sofosbuvir in Subjects Infected With Chronic Hepatitis-C (FOURward Study)

• Status: Completed
• Trial end date: 2015-12-17
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to determine whether the combination of Daclatasvir (DCV), Asunaprevir (ASV), BMS-791325 and Sofosbuvir is effective and safe in treating Hepatitis-C virus.

• 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:

• Males and Females ≥18 years of age, inclusive

• Chronic HCV infection Genotype 1 only

• Non-cirrhotic

• Treatment naive subjects with no previous exposure to an Interferon formulation (ie, IFNα, pegIFNα), ribavirin (RBV) or HCV Direct Acting Antiviral (DAA) (protease, polymerase inhibitor, etc.)

Exclusion Criteria:

• HCV Genotype other than Genotype 1

• Documented or suspected hepatocellular carcinoma

• Evidence of decompensated liver disease

• Contraindication(s) to Peg/RBV therapy