Safety and Efficacy of Daclatasvir (BMS-790052) Plus Standard of Care in Japanese Patients (Pegylated-interferon Alpha-2a and Ribavirin)
NCT ID: NCT01017575
Last Updated: 2015-09-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
55 participants
INTERVENTIONAL
2009-12-31
2011-10-31
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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Arm A (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Daclatasvir
Tablets, Oral, 10 mg, daily, 24-48 weeks
Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Arm B (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Daclatasvir
Tablets, Oral, 60 mg, daily, 24-48 weeks
Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Arm C (Placebo, plus Peginterferon alfa-2a, Ribavirin)
Treatment Naive
Placebo
Tablets, Oral, 0 mg, daily, 48 weeks
Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Arm D (Daclatasvir, plus peginterferon alfa-2a, Ribavirin)
Non-Responder
Daclatasvir
Tablets, Oral, 10 mg, daily, 24-48 weeks
Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Arm E (Daclatasvir, plus Peginterferon alfa-2a, Ribavirin)
Non-Responder
Daclatasvir
Tablets, Oral, 60 mg, daily, 24-48 weeks
Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Ribavirin
Tablets, Oral, 600 to 1000 mg based on weight, daily, 24-48 weeks
Interventions
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Daclatasvir
Tablets, Oral, 10 mg, daily, 24-48 weeks
Daclatasvir
Tablets, Oral, 60 mg, daily, 24-48 weeks
Placebo
Tablets, Oral, 0 mg, daily, 48 weeks
Peginterferon alfa-2a
Syringe, Subcutaneous, 180µg, weekly, 24-48 weeks
Ribavirin
Tablets, 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 (100,000 IU/mL) at screening
* The current standard of care naïve or non-responder
Exclusion Criteria
* HCC
* Co-infection with hepatitis B virus (HBV), 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
Chiba, Chiba, Japan
Local Institution
Kurume-Shi, Fukuoka, Japan
Local Institution
Okayama, Okayama-ken, Japan
Local Institution
Osaka, Osaka, Japan
Local Institution
Osaka, Osaka, Japan
Local Institution
Musashino-Shi, Tokyo, Japan
Countries
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Related Links
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Investigator Inquiry form
Other Identifiers
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AI444-022
Identifier Type: -
Identifier Source: org_study_id
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