Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha and Ribavirin)
NCT ID: NCT00874770
Last Updated: 2015-10-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
74 participants
INTERVENTIONAL
2009-06-30
2011-01-31
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 Peginterferon alpha-2a, ribavirin (A)
Active Comparator
Daclatasvir
Tablets, oral, 3 mg, Daily, 48 weeks
Peginterferon alpha-2a
Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
ribavirin
Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
Daclatasvir, Peginterferon alpha-2a, ribavirin (B)
Active Comparator
Daclatasvir
Tablets, oral, 10 mg, Daily, 48 weeks
Peginterferon alpha-2a
Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
ribavirin
Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
Daclatasvir, Peginterferon alpha-2a, ribavirin (C)
Active Comparator
Daclatasvir
Tablets, oral, 60 mg, Daily, 48 weeks
Peginterferon alpha-2a
Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
ribavirin
Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
Placebo, Peginterferon alpha-2a, ribavirin (D)
Placebo
Tablet, oral, 0 mg, Daily 48 weeks
Peginterferon alpha-2a
Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
ribavirin
Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
Interventions
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Daclatasvir
Tablets, oral, 3 mg, Daily, 48 weeks
Daclatasvir
Tablets, oral, 10 mg, Daily, 48 weeks
Daclatasvir
Tablets, oral, 60 mg, Daily, 48 weeks
Placebo
Tablet, oral, 0 mg, Daily 48 weeks
Peginterferon alpha-2a
Syringe, subcutaneous, 180 µg, Weekly, 48 weeks
ribavirin
Tablet, oral, 1000 or 1200 mg, based on weight, Daily, 48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV RNA viral load of ≥10\*5\* IU/mL (100,000 IU/mL) at screening
* Treatment naive
Exclusion Criteria
* Cirrhosis
* Coinfection with HIV or hepatitis B virus
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
University Of Colorado Denver & Hospital
Aurora, Colorado, United States
Yale University School Of Medicine
New Haven, Connecticut, United States
Mercy Medical Center
Baltimore, Maryland, United States
Llc Dba The Research Institute
Springfield, Massachusetts, United States
Veterans Affairs Medical Center
The Bronx, New York, 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
North Texas Research Institute
Arlington, Texas, United States
Metropolitan Research
Fairfax, Virginia, United States
Local Institution
Créteil, , France
Local Institution
Paris, , France
Local Institution
Vandœuvre-lès-Nancy, , France
Countries
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References
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Pol S, Ghalib RH, Rustgi VK, Martorell C, Everson GT, Tatum HA, Hezode C, Lim JK, Bronowicki JP, Abrams GA, Brau N, Morris DW, Thuluvath PJ, Reindollar RW, Yin PD, Diva U, Hindes R, McPhee F, Hernandez D, Wind-Rotolo M, Hughes EA, Schnittman S. Daclatasvir for previously untreated chronic hepatitis C genotype-1 infection: a randomised, parallel-group, double-blind, placebo-controlled, dose-finding, phase 2a trial. Lancet Infect Dis. 2012 Sep;12(9):671-7. doi: 10.1016/S1473-3099(12)70138-X. Epub 2012 Jun 18.
Related Links
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Investigator Inquiry form
Other Identifiers
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EUDRACT# 2009-010149-29
Identifier Type: -
Identifier Source: secondary_id
AI444-014
Identifier Type: -
Identifier Source: org_study_id
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