NCT01125189

Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients

A Phase 2b Study of Daclatasvir in Combination With Peg-Interferon Alfa-2a and Ribavirin in Treatment Naive Subjects With Chronic Hepatitis C Genotype 1 and 4 Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 558 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

To establish that at least 1 dose of daclatasvir combined with standard of care (pegylated interferon and ribavirin) is safe and well tolerated and demonstrates extended rapid virologic response rates at least 35% greater than those with placebo.

Conditions

• Hepatitis C Virus

Interventions

Type	Name	Description
DRUG	Daclatasvir	Tablets, oral, 20 mg, once daily, 12-24 weeks, depending on response
DRUG	Daclatasvir	Tablets, oral, 60 mg, once daily, 12-24 weeks, depending on response
DRUG	Placebo	Tablets, oral, 0 mg, once daily, 24 weeks
DRUG	peg-interferon alfa-2a	Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response
DRUG	ribavirin	Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response

Timeline

• Start date: 2010-07-01
• Primary completion: 2012-04-01
• Completion: 2012-08-01
• First posted: 2010-05-18
• Last updated: 2015-10-23
• Results posted: 2015-10-23

Locations

64 sites across 11 countries: United States, Australia, Canada, Denmark, Egypt, France, Germany, Italy, Mexico, Puerto Rico, Sweden