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

PHASE2CompletedINTERVENTIONAL
Enrollment

55

Participants

Timeline

Start Date

December 31, 2009

Primary Completion Date

October 31, 2011

Study Completion Date

October 31, 2011

Conditions
Hepatitis C Infection
Interventions
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

Trial Locations (6)

5438555

Local Institution, Osaka

7008558

Local Institution, Okayama

8300011

Local Institution, Kurume-Shi

Unknown

Local Institution, Chiba

545-8586

Local Institution, Osaka

180-0023

Local Institution, Musashino-Shi

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY

NCT01017575 - Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin) | Biotech Hunter | Biotech Hunter