Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care (Pegylated-interferon Alpha-2b and Ribavirin) in Japanese Patients
NCT ID: NCT01016912
Last Updated: 2015-10-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
51 participants
INTERVENTIONAL
2009-12-31
2010-09-30
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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Arm A (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
BMS-790052
Tablets, Oral, 10 mg, daily, 24-48 weeks
Peginterferon alfa-2b
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Ribavirin
Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Arm B (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
BMS-790052
Tablets, Oral, 60 mg, daily, 24-48 weeks
Peginterferon alfa-2b
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Ribavirin
Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Arm C (Placebo, plus Peginterferon alfa-2b, Ribavirin)
Treatment Naive
Placebo
Tablets, Oral, 0 mg, daily, 48 weeks
Peginterferon alfa-2b
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Ribavirin
Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Arm D (BMS-790052, plus peginterferon alfa-2b, Ribavirin)
Non-Responder
BMS-790052
Tablets, Oral, 10 mg, daily, 24-48 weeks
Peginterferon alfa-2b
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Ribavirin
Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Arm E (BMS-790052, plus Peginterferon alfa-2b, Ribavirin)
Non-Responder
BMS-790052
Tablets, Oral, 60 mg, daily, 24-48 weeks
Peginterferon alfa-2b
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Ribavirin
Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Interventions
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BMS-790052
Tablets, Oral, 10 mg, daily, 24-48 weeks
BMS-790052
Tablets, Oral, 60 mg, daily, 24-48 weeks
Placebo
Tablets, Oral, 0 mg, daily, 48 weeks
Peginterferon alfa-2b
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Ribavirin
Capsules, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HCV RNA viral load ≥10\*5\* IU/mL at screening
* Naïve or nonresponsive to the current standard of care
Exclusion Criteria
* Hepatocellular carcinoma
* Coinfection with hepatitis B virus, HIV-1 or HIV-2
20 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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Local Institution
Hiroshima, Hiroshima, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Kawasaki-Shi, Kanagawa, Japan
Local Institution
Suita-Shi, Osaka, Japan
Local Institution
Iruma-Gun, Saitama, Japan
Local Institution
Minato-Ku, Tokyo, Japan
Countries
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References
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Murakami E, Imamura M, Hayes CN, Abe H, Hiraga N, Honda Y, Ono A, Kosaka K, Kawaoka T, Tsuge M, Aikata H, Takahashi S, Miki D, Ochi H, Matsui H, Kanai A, Inaba T, McPhee F, Chayama K. Ultradeep sequencing study of chronic hepatitis C virus genotype 1 infection in patients treated with daclatasvir, peginterferon, and ribavirin. Antimicrob Agents Chemother. 2014;58(4):2105-12. doi: 10.1128/AAC.02068-13. Epub 2014 Jan 27.
Related Links
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Investigator Inquiry form
Other Identifiers
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AI444-021
Identifier Type: -
Identifier Source: org_study_id
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