NCT01017575

Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)

A Phase 2a Study of Daclatasvir in Combination With Peginterferon Alfa-2a(Pegasys®) and Ribavirin (Copegus®) in Japanese Subjects With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Bristol-Myers Squibb · Industry
• Sex: All
• Age: 20 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to identify at least 1 dose of Daclatasvir, that when combined with peginterferon-alfa (PegIFNα) and ribavirin (RBV) for the treatment of chronically infected HCV genotype 1 treatment-naïve and non-responder to standard of care subjects is safe, well tolerated, and efficacious

Conditions

• Hepatitis C Infection

Interventions

Type	Name	Description
DRUG	Daclatasvir	Tablets, Oral, 10 mg, daily, 24-48 weeks
DRUG	Daclatasvir	Tablets, Oral, 60 mg, daily, 24-48 weeks
DRUG	Placebo	Tablets, Oral, 0 mg, daily, 48 weeks
DRUG	Peginterferon alfa-2a	Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
DRUG	Ribavirin	Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks

Timeline

• Start date: 2009-12-01
• Primary completion: 2011-10-01
• Completion: 2011-10-01
• First posted: 2009-11-20
• Last updated: 2015-09-11
• Results posted: 2015-09-11

Locations

6 sites across 1 country: Japan