Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)

PHASE2CompletedINTERVENTIONAL
Enrollment

74

Participants

Timeline

Start Date

June 30, 2009

Primary Completion Date

November 30, 2009

Study Completion Date

January 31, 2011

Conditions
Hepatitis C Infection
Interventions
DRUG

Daclatasvir

Tablets, oral, 3 mg, Daily, 48 weeks

DRUG

Daclatasvir

Tablets, oral, 10 mg, Daily, 48 weeks

DRUG

Daclatasvir

Tablets, oral, 60 mg, Daily, 48 weeks

DRUG

Placebo

Tablet, oral, 0 mg, Daily 48 weeks

DRUG

Peginterferon alpha-2a

Syringe, subcutaneous, 180 µg, Weekly, 48 weeks

DRUG

ribavirin

Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks

Trial Locations (14)

10468

Veterans Affairs Medical Center, The Bronx

21202

Mercy Medical Center, Baltimore

22031

Metropolitan Research, Fairfax

28677

Carolinas Center For Liver Disease, Statesville

36116

Alabama Liver & Digestive Specialists (Alds), Montgomery

54511

Local Institution, Vandœuvre-lès-Nancy

74104

Options Health Research, Llc, Tulsa

74135

Healthcare Research Consultants, Tulsa

75679

Local Institution, Paris

76012

North Texas Research Institute, Arlington

80045

University Of Colorado Denver & Hospital, Aurora

94010

Local Institution, Créteil

06520

Yale University School Of Medicine, New Haven

01107

Llc Dba The Research Institute, Springfield

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY