Study of Daclatasvir (BMS-790052) Add-on to Standard of Care in Treatment- naïve Patients
NCT ID: NCT01125189
Last Updated: 2015-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
558 participants
INTERVENTIONAL
2010-07-31
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Daclatasvir plus peg-interferon alfa-2a and ribavirin (20 mg)
Daclatasvir
Tablets, oral, 20 mg, once daily, 12-24 weeks, depending on response
peg-interferon alfa-2a
Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response
ribavirin
Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response
Daclatasvir plus peg-interferon alfa-2a and ribavirin (60 mg)
Daclatasvir
Tablets, oral, 60 mg, once daily, 12-24 weeks, depending on response
peg-interferon alfa-2a
Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response
ribavirin
Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response
Placebo plus peg-interferon alfa-2a and ribavirin
Placebo
Tablets, oral, 0 mg, once daily, 24 weeks
peg-interferon alfa-2a
Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response
ribavirin
Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response
Interventions
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Daclatasvir
Tablets, oral, 20 mg, once daily, 12-24 weeks, depending on response
Daclatasvir
Tablets, oral, 60 mg, once daily, 12-24 weeks, depending on response
Placebo
Tablets, oral, 0 mg, once daily, 24 weeks
peg-interferon alfa-2a
Syringe, subcutaneous Injection, 180 µg, once weekly, 24 or 48 weeks depending on response
ribavirin
Tablets, oral, 1000 or 1200 mg based on weight, once daily, 24 or 48 weeks depending on response
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV RNA viral load of ≥100,000 IU/mL
* No previous exposure to interferon, pegIFNα, or RBV
* Results of a liver biopsy demonstrating absence of cirrhosis obtained ≤24 months prior to randomization. Compensated cirrhotics with Hepatitis C virus genotype 1 infection are eligible, but will be capped at 10% of the randomized study population (biopsy can be from any time period prior to randomization)
* Findings on ultrasound, computed tomography scan, or magnetic resonance imaging 12 months prior to randomization that do not demonstrate evidence of hepatocellular carcinoma
* Body mass index of 18 to 35 kg/m\^2
Exclusion Criteria
* Evidence of a medical condition associated with chronic liver disease other than HCV
* Evidence of decompensated cirrhosis based on radiologic criteria or biopsy
18 Years
70 Years
ALL
No
Sponsors
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Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Alabama Liver & Digestive Specialists (Alds)
Montgomery, Alabama, United States
Scripps Clinic
La Jolla, California, United States
Cli
Los Angeles, California, United States
Desta Digestive Disease Medical Center
San Diego, California, United States
University Of California, San Francisco/Sf General Hospital
San Francisco, California, United States
California Pacific Medical Center
San Francisco, California, United States
Kaiser Permanente Medical Center
San Francisco, California, United States
Transplant Center And Hepatology Clinic, B-154
Aurora, Colorado, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
University Of Florida Hepatology
Gainesville, Florida, United States
University Of Miami
Miami, Florida, United States
Miami Research Associates
South Miami, Florida, United States
Indiana University
Indianapolis, Indiana, United States
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Mercy Medical Center
Baltimore, Maryland, United States
Digestive Disease Associates, P.A.
Baltimore, Maryland, United States
Johns Hopkins University
Lutherville, Maryland, United States
Claudia T. Martorell, Md, Llc
Springfield, Massachusetts, United States
James Sungsik Park, M.D. C.N.S.C.
Great Neck, New York, United States
Upper Delaware Valley Infectious Diseases, Pc
Monticello, New York, United States
James J Peters Vamc
The Bronx, New York, United States
University Of North Carolina At Chapel Hill School Of Med
Chapel Hill, North Carolina, United States
Carolinas Center For Liver Disease
Statesville, North Carolina, United States
Options Health Research, Llc
Tulsa, Oklahoma, United States
Healthcare Research Consultants
Tulsa, Oklahoma, United States
University Of Pennsylvania
Philadelphia, Pennsylvania, United States
University Gastroenterology
Providence, Rhode Island, United States
Nashville Medical Research Institute
Nashville, Tennessee, United States
North Texas Research Institute
Arlington, Texas, United States
St. Luke'S Episcopal Hospital - Baylor College Of Medicine
Houston, Texas, United States
Alamo Medical Research
San Antonio, Texas, United States
Metropolitan Research
Fairfax, Virginia, United States
Dean Clinic
Madison, Wisconsin, United States
Local Institution
Darlinghurst, New South Wales, Australia
Local Institution
Westmead Nsw, New South Wales, Australia
Local Institution
Woolloongabba, Queensland, Australia
Local Institution
Adelaide, South Australia, Australia
Local Institution
Clayton Vic, Victoria, Australia
Local Institution
Camperdown, , Australia
Local Institution
Edmonton, Alberta, Canada
Local Institution
Vancouver, British Columbia, Canada
Local Institution
Victoria, British Columbia, Canada
Local institution
Toronto, Ontario, Canada
Local Institution
Toronto, Ontario, Canada
Local Institution
Aarhus, , Denmark
Local Institution
Hvidovre, , Denmark
Local Institution
Odense, , Denmark
Local Institution
Shebin Elkom, Monufia Governorate, Egypt
Local Institution
Cairo, , Egypt
Local Institution
Créteil, , France
Local Institution
Marseille, , France
Local Institution
Montpellier, , France
Local Instituition
Paris, , France
Local Institution
Paris, , France
Local Institution
Düsseldorf, , Germany
Local Institution
Essen, , Germany
Local Institution
Frankfurt, , Germany
Local Institution
Hamburg, , Germany
Local Institution
Cisanello (pisa), , Italy
Local Institution
Pavia, , Italy
Local Institution
Guadalajara, Jalisco, Mexico
Local Institution
San Juan, , Puerto Rico
Local Institution
Gothenburg, , Sweden
Local Institution
Stockholm, , Sweden
Countries
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References
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Hezode C, Hirschfield GM, Ghesquiere W, Sievert W, Rodriguez-Torres M, Shafran SD, Thuluvath PJ, Tatum HA, Waked I, Esmat G, Lawitz EJ, Rustgi VK, Pol S, Weis N, Pockros PJ, Bourliere M, Serfaty L, Vierling JM, Fried MW, Weiland O, Brunetto MR, Everson GT, Zeuzem S, Kwo PY, Sulkowski M, Brau N, Hernandez D, McPhee F, Wind-Rotolo M, Liu Z, Noviello S, Hughes EA, Yin PD, Schnittman S. Daclatasvir plus peginterferon alfa and ribavirin for treatment-naive chronic hepatitis C genotype 1 or 4 infection: a randomised study. Gut. 2015 Jun;64(6):948-56. doi: 10.1136/gutjnl-2014-307498. Epub 2014 Jul 30.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2010-018295-24
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI444-010
Identifier Type: -
Identifier Source: org_study_id
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