An Anti-viral Combination Study With Japanese Hepatitis C Infection (HCV) Subject
NCT ID: NCT01051414
Last Updated: 2015-10-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
43 participants
INTERVENTIONAL
2010-04-30
2012-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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BMS-790052 + BMS-650032
BMS-790052
Tablets, Oral, 60 mg, daily, 24 weeks
BMS-650032
Tablets, Oral, 1200 mg, daily, 24 weeks
Interventions
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BMS-790052
Tablets, Oral, 60 mg, daily, 24 weeks
BMS-650032
Tablets, Oral, 1200 mg, daily, 24 weeks
Eligibility Criteria
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Inclusion Criteria
* HCV RNA viral load of ≥ 10\*5\* IU/mL (100,000 IU/mL) at screening
Exclusion Criteria
* Evidence of HCC
* Co-infection with hepatitis B virus, HIV
20 Years
75 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
Minato-Ku, Tokyo, Japan
Countries
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References
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Kao JH, Jensen DM, Manns MP, Jacobson I, Kumada H, Toyota J, Heo J, Yoffe B, Sievert W, Bessone F, Peng CY, Roberts SK, Lee YJ, Bhore R, Mendez P, Hughes E, Noviello S. Daclatasvir plus asunaprevir for HCV genotype 1b infection in patients with or without compensated cirrhosis: a pooled analysis. Liver Int. 2016 Jul;36(7):954-62. doi: 10.1111/liv.13049. Epub 2016 Jan 24.
Suzuki Y, Ikeda K, Suzuki F, Toyota J, Karino Y, Chayama K, Kawakami Y, Ishikawa H, Watanabe H, Hu W, Eley T, McPhee F, Hughes E, Kumada H. Dual oral therapy with daclatasvir and asunaprevir for patients with HCV genotype 1b infection and limited treatment options. J Hepatol. 2013 Apr;58(4):655-62. doi: 10.1016/j.jhep.2012.09.037. Epub 2012 Nov 23.
Karino Y, Toyota J, Ikeda K, Suzuki F, Chayama K, Kawakami Y, Ishikawa H, Watanabe H, Hernandez D, Yu F, McPhee F, Kumada H. Characterization of virologic escape in hepatitis C virus genotype 1b patients treated with the direct-acting antivirals daclatasvir and asunaprevir. J Hepatol. 2013 Apr;58(4):646-54. doi: 10.1016/j.jhep.2012.11.012. Epub 2012 Nov 22.
Related Links
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Investigator Inquiry form
Other Identifiers
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AI447-017
Identifier Type: -
Identifier Source: org_study_id
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