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Rapid Hepatitis C Elimination Trial- A Pilot Study of Daclatasvir/Asunaprevir/BMS-791325 With or Without Ribavirin To Treat Hepatitis C Virus

NCT ID: NCT02098616

Last Updated: 2016-04-19

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

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-07-31

Study Completion Date

2016-02-29

Brief Summary

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The purpose of this study is to determine whether treatment with Daclatasvir/Asunaprevir/BMS-791325, with or without ribavirin, for 8, 6, or 4 weeks is feasible for the treatment of genotype 1a chronic hepatitis C in patients without cirrhosis.

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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

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm 1

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 8 weeks

Group Type EXPERIMENTAL

DCV/ASV/BMS-791325

Intervention Type DRUG

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) orally twice a day

Arm 2

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 6, 8 or 12 weeks

Group Type EXPERIMENTAL

DCV/ASV/BMS-791325

Intervention Type DRUG

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) orally twice a day

Arm 3

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day for 4 weeks

Group Type EXPERIMENTAL

DCV/ASV/BMS-791325

Intervention Type DRUG

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) orally twice a day

Arm A

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 8 weeks

Group Type EXPERIMENTAL

DCV/ASV/BMS-791325 + RBV

Intervention Type DRUG

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day

Arm B

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 6, 8 or 12 weeks

Group Type EXPERIMENTAL

DCV/ASV/BMS-791325 + RBV

Intervention Type DRUG

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day

Arm C

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day for 4 weeks

Group Type EXPERIMENTAL

DCV/ASV/BMS-791325 + RBV

Intervention Type DRUG

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day

Interventions

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DCV/ASV/BMS-791325

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) orally twice a day

Intervention Type DRUG

DCV/ASV/BMS-791325 + RBV

Fixed dose combination (Daclatasvir 30 mg, Asunaprevir 200 mg and BMS-791325 75 mg) tablet orally twice a day plus weight based ribavirin orally twice a day

Intervention Type DRUG

Other Intervention Names

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Fixed Dose Combination (FDC) of Daclatasvir/Asunaprevir/BMS-791325

Eligibility Criteria

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Inclusion Criteria

* Subjects chronically infected with HCV genotype 1a
* HCV RNA ≥ 10,000 IU/mL at screening
* Treatment-naïve subjects with no previous exposure to an interferon formulation (ie, IFNα, pegIFNα), ribavirin (RBV), or HCV direct acting antiviral (DAA; protease, polymerase inhibitor, etc.)

Exclusion Criteria

* Evidence of cirrhosis
* Liver or any other organ transplant
* Current or known history of cancer within 5 years prior to enrollment
* Documented or suspected hepatocellular carcinoma (HCC)
* Not eligible for sofosbuvir + pegylated interferon + ribavirin therapy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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VA Long Beach Healthcare System

FED

Sponsor Role collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

Timothy Morgan, MD

OTHER

Sponsor Role lead

Responsible Party

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Timothy Morgan, MD

Chief, Hepatology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Timothy R. Morgan, MD

Role: PRINCIPAL_INVESTIGATOR

VA Long Beach Healthcare System/Southern California Institute for Research and Education

Locations

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VA Long Beach Healthcare System

Long Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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AI443-128

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB #1285

Identifier Type: -

Identifier Source: org_study_id

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