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A Phase 3 Study of a Daclatasvir/Asunaprevir/BMS-791325 Fixed Dose Combination (FDC) in Subjects With Chronic Hepatitis C Genotype 1

NCT ID: NCT02170727

Last Updated: 2020-10-29

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

199 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-06-26

Study Completion Date

2015-09-09

Brief Summary

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To demonstrate the effectiveness of Daclatasvir (DCV) 3 Direct Acting Antivirals (DAA) fixed dose combination in Genotype 1 Chronic Hepatitis C subjects.

Detailed Description

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US National Institutes of Health Division of AIDs (DAIDS)

Conditions

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Hepatitis C Virus

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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Arm 1 : DCV/ASV/BMS-791325

DCV 30 mg (as the free base) / Asunaprevir (ASV) 200 mg / BMS-791325 75 mg FDC tablet orally twice daily for 12 weeks

Group Type EXPERIMENTAL

DCV/ASV/BMS-791325

Intervention Type DRUG

Interventions

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DCV/ASV/BMS-791325

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Subject chronically infected with HCV genotype 1 (GT-1)
* Subject without cirrhosis or with compensated cirrhosis (Child Pugh Class A)
* HCV RNA ≥ 10,000 IU/mL at screening
* Treatment-naïve subject with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), Ribavirin (RBV), or HCV DAA (protease, polymerase inhibitor, etc.)
* Interferon (IFN) experienced subject who have received previous treatment with IFNα, with or without RBV

Exclusion Criteria

* Liver or any other transplant (including hematopoietic stem cell transplants) other than cornea and hair;
* Current or known history of cancer (except in situ carcinoma of the cervix or adequately treated basal or squamous cell carcinoma of the skin) within 5 years prior to screening;
* Documented or suspected hepatocellular carcinoma (HCC), as evidenced by previously obtained imaging studies or liver biopsy (or on a screening imaging study/liver biopsy if this was performed);
* Evidence of decompensated liver disease including, but not limited to, radiologic criteria, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
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

Kazan', , Russia

Site Status

Local Institution

Moscow, , Russia

Site Status

Local Institution

Busan, , South Korea

Site Status

Local Institution

Busan, , South Korea

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Local Institution

Gyeonggi-do, , South Korea

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Local Institution

Gyeonggi-do, , South Korea

Site Status

Local Institution

Gyeongsangnam-do, , South Korea

Site Status

Local Institution

Inchoen, , South Korea

Site Status

Local Institution

Seoul, , South Korea

Site Status

Local Institution

Seoul, , South Korea

Site Status

Local Institution

Seoul, , South Korea

Site Status

Local Institution

Seoul, , South Korea

Site Status

Local Institution

Kaohsiung City, , Taiwan

Site Status

Local Institution

Kaohsiung City, , Taiwan

Site Status

Local Institution

Taichung, , Taiwan

Site Status

Local Institution

Taichung, , Taiwan

Site Status

Local Institution

Tainan City, , Taiwan

Site Status

Local Institution

Taipei, , Taiwan

Site Status

Local Institution

Taipei, , Taiwan

Site Status

Local Institution

Taoyuan District, , Taiwan

Site Status

Countries

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Russia South Korea Taiwan

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

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

BMS Clinical Trial Patient Recruiting

Other Identifiers

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AI443-123

Identifier Type: -

Identifier Source: org_study_id