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A Phase 3 Study in Combination With BMS-790052 and BMS-650032 in Japanese Hepatitis C Virus (HCV) Patients

NCT ID: NCT01497834

Last Updated: 2015-10-09

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-06-30

Brief Summary

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The purpose of this study is to assess the anti-viral activity of BMS-790052 and BMS-650032 combination therapy in Japanese subjects.

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UNITY 3: A Japanese Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 in Subjects With Genotype 1 Chronic Hepatitis C

NCT02123654

Hepatitis C Virus Infection
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Three-year Follow-up Study of Subjects Who Participated in a Previous Asunaprevir (BMS-650032) and/or Daclatasvir (BMS-790052) Chronic Hepatitis C Clinical Trial

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Detailed Description

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Conditions

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Hepatitis C

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Daclatasvir + Asunaprevir

Group Type EXPERIMENTAL

BMS-790052 (Daclatasvir)

Intervention Type DRUG

Tablets, Oral, 60mg, Once daily, 24 weeks

BMS-650032 (Asunaprevir)

Intervention Type DRUG

Capsules, Oral, 100mg, Twice daily, 24 weeks

Interventions

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BMS-790052 (Daclatasvir)

Tablets, Oral, 60mg, Once daily, 24 weeks

Intervention Type DRUG

BMS-650032 (Asunaprevir)

Capsules, Oral, 100mg, Twice daily, 24 weeks

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Chronic HCV-1b infected patient
* HCV RNA viral load of ≥ 100,000 IU/mL at screening
* Ages 20 to 75 years
* Non-responder to Interferon plus Ribavirin therapy
* Patient who has been excluded from interferon/ribavirin therapy or intolerant for Interferon/Ribavirin therapy

Exclusion Criteria

Patients who have -

* Hepatocellular carcinoma
* Co-infection with Hepatitis B virus (HBV) or Human Immunodeficiency Virus (HIV)
* Severe or uncontrollable complication
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Local Institution

Chiba, Chiba, Japan

Site Status

Local Institution

Fukuoka, Fukuoka, Japan

Site Status

Local Institution

Kurume, Fukuoka, Japan

Site Status

Local Institution

Ogaki-shi, Gifu, Japan

Site Status

Local Institution

Hiroshima, Hiroshima, Japan

Site Status

Local Institution

Sapporo, Hokkaido, Japan

Site Status

Local Institution

Amagasaki-shi, Hyōgo, Japan

Site Status

Local Institution

Kanazawa, Ishikawa-ken, Japan

Site Status

Local Institution

Takamatsu, Kagawa-ken, Japan

Site Status

Local Institution

Kagoshima, Kagoshima-ken, Japan

Site Status

Local Institution

Kawasaki-Shi, Kanagawa, Japan

Site Status

Local Institution

Sendai, Miyagi, Japan

Site Status

Local Institution

Okayama, Okayama-ken, Japan

Site Status

Local Institution

Osaka, Osaka, Japan

Site Status

Local Institution

Osaka-sayama-shi, Osaka, Japan

Site Status

Local Institution

Suita, Osaka, Japan

Site Status

Local Institution

Suita-shi, Osaka, Japan

Site Status

Local Institution

Iruma-Gun, Saitama, Japan

Site Status

Local Institution

Bunkyo-Ku, Tokyo, Japan

Site Status

Local Institution

Minato-ku, Tokyo, Japan

Site Status

Local Institution

Musashino-shi, Tokyo, Japan

Site Status

Local Institution

Shinagawa-ku, Tokyo, Japan

Site Status

Local Institution

Chuo-shi, Yamanashi, Japan

Site Status

Countries

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Japan

References

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Hernandez D, Yu F, Huang X, Kirov S, Pant S, McPhee F. Impact of Pre-existing NS5A-L31 or -Y93H Minor Variants on Response Rates in Patients Infected with HCV Genotype-1b Treated with Daclatasvir/Asunaprevir. Adv Ther. 2016 Jul;33(7):1169-79. doi: 10.1007/s12325-016-0354-1. Epub 2016 Jun 10.

Reference Type DERIVED
PMID: 27287851 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26683763 (View on PubMed)

Kumada H, Suzuki Y, Ikeda K, Toyota J, Karino Y, Chayama K, Kawakami Y, Ido A, Yamamoto K, Takaguchi K, Izumi N, Koike K, Takehara T, Kawada N, Sata M, Miyagoshi H, Eley T, McPhee F, Damokosh A, Ishikawa H, Hughes E. Daclatasvir plus asunaprevir for chronic HCV genotype 1b infection. Hepatology. 2014 Jun;59(6):2083-91. doi: 10.1002/hep.27113. Epub 2014 Apr 1.

Reference Type DERIVED
PMID: 24604476 (View on PubMed)

Related Links

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http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

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AI447-026

Identifier Type: -

Identifier Source: org_study_id

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