UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C
NCT ID: NCT02123654
Last Updated: 2015-09-18
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
PHASE3
297 participants
INTERVENTIONAL
2014-04-30
2015-08-31
Brief Summary
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Detailed Description
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Ribonucleic acid (RNA)
End of Treatment (EOT)
Triple Direct Acting Antivirals (3DAA)
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Arm 1: DCV 3DAA + Placebo for DCV/Placebo for ASV
DCV 3DAA tablet orally twice daily for 12 weeks + Placebo for DCV tablet orally once daily and Placebo for ASV capsule orally twice daily for 24 weeks (Double blind)
DCV 3DAA
Placebo for Daclatasvir
Placebo for Asunaprevir
Arm 2: DCV/ASV + Placebo for DCV 3DAA
Daclatasvir 60 mg tablet orally once daily and Asunaprevir 100 mg capsule orally twice daily for 24 weeks + Placebo for DCV 3DAA tablet orally twice daily for 12 weeks (Double blind)
Daclatasvir
Asunaprevir
Placebo for DCV 3DAA
DCV 3DAA
DCV 3DAA (open label) Tablet orally twice daily for 12 weeks
DCV 3DAA
Interventions
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Daclatasvir
Asunaprevir
DCV 3DAA
Placebo for DCV 3DAA
Placebo for Daclatasvir
Placebo for Asunaprevir
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Subjects chronically infected with HCV GT-1
* HCV RNA viral load of ≥ 100,000 IU/mL
Exclusion Criteria
* Co-infection with Hepatitis B virus (HBV) or Human immunodeficiency virus (HIV)
* Severe or uncontrollable complication
20 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
Nagoya, Aichi-ken, Japan
Local Institution
Nagoya, Aichi-ken, Japan
Local Institution
Fukui-shi, Fukui, Japan
Local Institution
Fukuoka, Fukuoka, Japan
Local Institution
Kurume-shi, Fukuoka, Japan
Local Institution
Gifu, Gifu, Japan
Local Institution
Ogaki-shi, Gifu, Japan
Local Institution
Takasaki, Gunma, Japan
Local Institution
Hiroshima, Hiroshima, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Sapporo, Hokkaido, Japan
Local Institution
Kobe, Hyōgo, Japan
Local Institution
Kanazawa, Ishikawa-ken, Japan
Local Institution
Takamatsu, Kagawa-ken, Japan
Local Institution
Kagoshima, Kagoshima-ken, Japan
Local Institution
Kawasaki-shi, Kanagawa, Japan
Local Institution
Yokohama, Kanagawa, Japan
Local Institution
Kumamoto, Kumamoto, Japan
Local Institution
Kyoto, Kyoto, Japan
Local Institution
Miyazaki, Miyazaki, Japan
Local Institution
Kashihara, Nara, Japan
Local Institution
Okayama, Okayama-ken, Japan
Local Institution
Osaka, Osaka, Japan
Local Institution
Osaka, Osaka, Japan
Local Institution
Suita, Osaka, Japan
Local Institution
Suita-shi, Osaka, Japan
Local Institution
Saga, Saga-ken, Japan
Local Institution
Iruma-gun, Saitama, Japan
Local Institution
Bunkyo-ku, Tokyo, Japan
Local Institution
Minato-ku, Tokyo, Japan
Local Institution
Musashino-shi, Tokyo, Japan
Local Institution
Shinjuku-Ku, Tokyo, Japan
Local Institution
Yamagata, Yamagata, Japan
Local Institution
Chuo-shi, Yamanashi, Japan
Local Institution
Nishinomiya-shi, , Japan
Countries
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Related Links
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BMS clinical trial educational resource
Investigator Inquiry form
Other Identifiers
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AI443-117
Identifier Type: -
Identifier Source: org_study_id
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