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

PHASE2CompletedINTERVENTIONAL
Enrollment

558

Participants

Timeline

Start Date

July 31, 2010

Primary Completion Date

April 30, 2012

Study Completion Date

August 31, 2012

Conditions
Hepatitis C Virus
Interventions
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

Trial Locations (64)

2010

Local Institution, Darlinghurst

2145

Local Institution, Westmead Nsw

2650

Local Institution, Hvidovre

3168

Local Institution, Clayton Vic

4102

Local Institution, Woolloongabba

5000

Local Institution, Adelaide

Local Institution, Odense

8200

Local Institution, Aarhus

10468

James J Peters Vamc, The Bronx

11201

James Sungsik Park, M.D. C.N.S.C., Great Neck

11559

Local Institution, Cairo

12701

Upper Delaware Valley Infectious Diseases, Pc, Monticello

13285

Local Institution, Marseille

19104

University Of Pennsylvania, Philadelphia

20099

Local Institution, Hamburg

21093

Johns Hopkins University, Lutherville

21202

Mercy Medical Center, Baltimore

21229

Digestive Disease Associates, P.A., Baltimore

22031

Metropolitan Research, Fairfax

27100

Local Institution, Pavia

27599

University Of North Carolina At Chapel Hill School Of Med, Chapel Hill

28677

Carolinas Center For Liver Disease, Statesville

32610

University Of Florida Hepatology, Gainesville

33136

University Of Miami, Miami

33143

Miami Research Associates, South Miami

34295

Local Institution, Montpellier

35111

Local Institution, Shebin Elkom

36116

Alabama Liver & Digestive Specialists (Alds), Montgomery

37205

Nashville Medical Research Institute, Nashville

40237

Local Institution, Düsseldorf

44340

Local Institution, Guadalajara

45122

Local Institution, Essen

46202

Indiana University, Indianapolis

53715

Dean Clinic, Madison

56124

Local Institution, Cisanello (pisa)

60590

Local Institution, Frankfurt

70121

Ochsner Clinic Foundation, New Orleans

74104

Options Health Research, Llc, Tulsa

74135

Healthcare Research Consultants, Tulsa

75571

Local Instituition, Paris

75679

Local Institution, Paris

76012

North Texas Research Institute, Arlington

77030

St. Luke'S Episcopal Hospital - Baylor College Of Medicine, Houston

78215

Alamo Medical Research, San Antonio

80045

Transplant Center And Hepatology Clinic, B-154, Aurora

90048

Cli, Los Angeles

92037

Scripps Clinic, La Jolla

92114

Desta Digestive Disease Medical Center, San Diego

94000

Local Institution, Créteil

94110

University Of California, San Francisco/Sf General Hospital, San Francisco

94115

California Pacific Medical Center, San Francisco

94118

Kaiser Permanente Medical Center, San Francisco

06520

Yale University School Of Medicine, New Haven

01105

Claudia T. Martorell, Md, Llc, Springfield

02905

University Gastroenterology, Providence

NSW 2050

Local Institution, Camperdown

T6G 2B7

Local Institution, Edmonton

V6Z 2K5

Local Institution, Vancouver

V8V 3P9

Local Institution, Victoria

M5G 2N2

Local institution, Toronto

M5T 2S8

Local Institution, Toronto

00927

Local Institution, San Juan

SE-416 85

Local Institution, Gothenburg

141 86

Local Institution, Stockholm

Sponsors
All Listed Sponsors
lead

Bristol-Myers Squibb

INDUSTRY