NCT01359644

Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care

Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination With BMS-790052 With or Without Ribavirin in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotypes 1, 2, or 3

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 350 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment

Conditions

• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	PSI-7977	Tablets, oral, 400 mg, once daily
DRUG	Daclatasvir	Tablets, oral, 60 mg, once daily
DRUG	Ribavirin	Tablets, oral, 200 mg

Timeline

• Start date: 2011-06-01
• Primary completion: 2013-01-01
• Completion: 2013-10-01
• First posted: 2011-05-25
• Last updated: 2015-10-23
• Results posted: 2015-10-23

Locations

18 sites across 2 countries: United States, Puerto Rico