Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT- 267 (ABT-450/r/ABT-267) in Japanese Adults With Genotype 2 Chronic Hepatitis C Virus (HCV) Infection

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

171 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2015-09-30

Brief Summary

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This is a Phase 3, randomized, open-label, multicenter study, enrolling non-cirrhotic and cirrhotic subjects. The purpose of this study is to evaluate the efficacy and safety of ABT-450/r/ABT-267 co-administered with weight-based RBV for 12 or 16 weeks in adult chronic HCV genotype 2-infected treatment-naïve and interferon (IFN) treatment-experienced subjects with and without compensated cirrhosis.

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Detailed Description

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Conditions

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Hepatitis C Virus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABT-450/r/ABT-267 plus RBV for 12 weeks

ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based ribavirin (RBV; 400 to 1,000 mg/day, divided twice daily) for 12 weeks

Group Type EXPERIMENTAL

ABT-450/r/ABT-267

Intervention Type DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267

Ribavirin

Intervention Type DRUG

Capsule

ABT-450/r/ABT-267 plus RBV for 16 weeks

ABT-450/r/ABT-267 (150/100/25 mg once daily) plus weight-based RBV (400 to 1,000 mg/day, divided twice daily) for 16 weeks

Group Type EXPERIMENTAL

ABT-450/r/ABT-267

Intervention Type DRUG

Tablet; ABT-450 coformulated with ritonavir and ABT-267

Ribavirin

Intervention Type DRUG

Capsule

Interventions

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ABT-450/r/ABT-267

Tablet; ABT-450 coformulated with ritonavir and ABT-267

Intervention Type DRUG

Ribavirin

Capsule

Intervention Type DRUG

Other Intervention Names

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ABT-267 also known as ombitasvir ABT-450 also known as paritaprevir ritonavir also known as Norvir VIEKIRAX Combination Tablets VIEKIRA Combination Tablets Technivie Qurevo

Eligibility Criteria

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Inclusion Criteria

* Chronic HCV-infection prior to study enrollment
* Screening laboratory result indicating HCV genotype 2 infection
* Subject has plasma HCV ribonucleic acid (RNA) level greater than 10,000 IU/mL at Screening
* Voluntarily sign an informed consent

Exclusion Criteria

* Co-infection of Hepatitis B Virus (HBV), human immunodeficiency virus (HIV) and any HCV genotype other than genotype 2
* Prior therapy with direct acting antiviral agents for the treatment of HCV, including telaprevir, simeprevir and boceprevir
* Any cause of liver disease other than chronic HCV-infection, including but not limited to the following: hemochromatosis; alpha-1 antitrypsin deficiency; Wilson's disease; autoimmune hepatitis; alcoholic liver disease; drug-related liver disease
* Clinically significant laboratory abnormalities
* Uncontrolled clinically significant disease, disorder or medical illness

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No