Phase III BMS-790052 Add-On to Peg-Interferon Alfa-2a and Ribavirin in Naive Hepatitis C
NCT ID: NCT01448044
Last Updated: 2015-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
152 participants
INTERVENTIONAL
2011-12-31
2014-01-31
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
TRIPLE
Study Groups
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BMS-790052 + PegIFNα-2a + Ribavirin
* BMS-790052 60 mg Tablets, Oral, once daily for 24 weeks
* PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 24 or 48 weeks depending on response
* Ribavirin 400 mg (2 tablets for participants \< 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 24 or 48 weeks depending on response
BMS-790052 (NS5A Replication Complex Inhibitor)
Pegylated-interferon alfa 2a
Ribavirin
Placebo matching BMS-790052 + PegIFNα-2a + Ribavirin
* Placebo matching BMS-790052 0 mg Tablets, Oral, once daily for 48 weeks
* PegIFNα-2a 180 μg Subcutaneous Injection, once weekly for 48 weeks
* Ribavirin 400 mg (2 tablets for participants \< 75 kg) or 600 mg (3 tablets for participants ≥ 75 kg) in the morning and 600 mg (3 tablets) in the evening, Oral for 48 weeks
Placebo matching BMS-790052
Pegylated-interferon alfa 2a
Ribavirin
Interventions
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BMS-790052 (NS5A Replication Complex Inhibitor)
Placebo matching BMS-790052
Pegylated-interferon alfa 2a
Ribavirin
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV RNA viral load of ≥ 10,000 IU/mL
* No previous exposure to an interferon formulation, RBV or HCV direct antiviral agent
* Results of a liver biopsy obtained within three years prior to enrollment to demonstrate the absence of cirrhosis. Participants with compensated cirrhosis are permitted, however, and any prior biopsy is permitted
Exclusion Criteria
* Documented or suspected Hepatocellular carcinoma (HCC)
* Positive for Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus-1 (HIV-1)/HIV-2 antibody at screening
18 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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Scti Research Foundation
San Clemente, California, United States
Umass Memorial Medical Center
Worcester, Massachusetts, United States
University Gastroenterology
Providence, Rhode Island, United States
Metropolitan Research
Annandale, Virginia, United States
Local Institution
Bondy, , France
Local Institution
Créteil, , France
Local Institution
La Roche-sur-Yon, , France
Local Institution
Marseille, , France
Local Institution
Nice, , France
Local Institution
Orléans, , France
Local Institution
Paris, , France
Local Institution
Paris, , France
Local Institution
Strasbourg, , France
Local Institution
Toulouse, , France
Local Institution
Villejuif, , France
Local Institution
Thesaloniki, , Greece
Local Institution
Roma, , Italy
Local Institution
Torino, , Italy
Local Institution
San Juan, , Puerto Rico
Local Institution
A Coruña, , Spain
Local Institution
Barcelona, , Spain
Local Institution
Barcelona, , Spain
Local Institution
Madrid, , Spain
Local Institution
London, Greater London, United Kingdom
Local Institution
London, Greater London, United Kingdom
Local Institution
London, Greater London, United Kingdom
Countries
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References
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Hezode C, Alric L, Brown A, Hassanein T, Rizzetto M, Buti M, Bourliere M, Thabut D, Molina E, Rustgi V, Samuel D, McPhee F, Liu Z, Yin PD, Hughes E, Treitel M; COMMAND-4 study team. Randomized controlled trial of the NS5A inhibitor daclatasvir plus pegylated interferon and ribavirin for HCV genotype-4 (COMMAND-4). Antivir Ther. 2015 Aug 27;21(3):195-205. doi: 10.3851/IMP2985. Online ahead of print.
Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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2011-002793-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
AI444-042
Identifier Type: -
Identifier Source: org_study_id
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