A Study to Evaluate the Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1, 2, 4, 5 or 6 Infection and Compensated Cirrhosis

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-12-07

Study Completion Date

2017-02-10

Brief Summary

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The purpose of this study is to assess the safety and efficacy of ABT-493/ABT-530 following 12 weeks of treatment in adults with chronic Hepatitis C Virus Infection genotype 1, 2, 4, 5 or 6 infection and compensated cirrhosis.

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Detailed Description

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Conditions

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Hepatitis C Virus Infection Chronic Hepatitis C Compensated Cirrhosis

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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ABT-493/ABT-530

ABT-493/ABT-530 (300 mg/120 mg) coformulated once daily (QD) for 12 weeks.

Group Type EXPERIMENTAL

ABT-493/ABT-530

Intervention Type DRUG

Tablet; ABT-493 coformulated with ABT-530

Interventions

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ABT-493/ABT-530

Tablet; ABT-493 coformulated with ABT-530

Intervention Type DRUG

Other Intervention Names

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ABT-493 also known as glecaprevir ABT-530 also known as pibrentasvir MAVYRET

Eligibility Criteria

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Inclusion Criteria

* Screening laboratory result indicating hepatitis C virus (HCV) Genotype 1, 2, 4, 5 or 6 (GT1,2,4,5,6) infection
* Chronic HCV infection
* Subject must be HCV treatment-naïve or have failed prior HCV treatment
* Subject must have documented compensated cirrhosis and no current or past clinical evidence of decompensated liver disease

Exclusion Criteria

* Positive test result at screening for Hepatitis B surface antigen or anti-human immunodeficiency virus (anti-HIV) antibody
* HCV genotype performed during screening indicating co-infection with more than 1 HCV genotype
* Consideration by the investigator, for any reason, that the subject is an unsuitable candidate to receive ABT-493/ABT-530

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No