Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) in Japanese Adults With Subgenotype 1b Chronic Hepatitis C Virus (HCV) Infection

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

363 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-10-31

Brief Summary

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This is a phase 3, double-blinded, multicenter study. The study will consist of 2 substudies: Substudy 1 (SS1) will be double-blinded and enroll non-cirrhotic subjects and Substudy 2 (SS2) will be open label and enroll subjects with compensated cirrhosis.

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Detailed Description

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Conditions

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Chronic Hepatitis C Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Substudy 1, Arm A: DB 2-DAA

Double-blind (DB) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2 direct-acting antiviral agents \[2-DAA\]) once daily (QD) for 12 weeks in participants without cirrhosis

Group Type EXPERIMENTAL

ABT-450/r/ABT-267

Intervention Type DRUG

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

Substudy 1, Arm B: DB Placebo, Followed by OL 2-DAA

DB placebo QD for 12 weeks followed by open-label (OL) 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants without cirrhosis

Group Type PLACEBO_COMPARATOR

ABT-450/r/ABT-267

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Tablet

Substudy 2, Arm C: OL 2-DAA

OL 150 mg ABT-450/100 mg ritonavir/25 mg ABT-267 (2-DAA) QD for 12 weeks in participants with compensated cirrhosis

Group Type EXPERIMENTAL

ABT-450/r/ABT-267

Intervention Type DRUG

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

Interventions

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ABT-450/r/ABT-267

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

Intervention Type DRUG

Placebo

Tablet

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 Qurevo Technivie VIEKIRA Combination Tablets

Eligibility Criteria

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Inclusion Criteria

* Chronic HCV-infection prior to study enrollment
* Screening laboratory result indicating HCV subgenotype 1b infection
* Subject has plasma HCV RNA level greater than 10,000 IU/mL at Screening
* Voluntarily sign an informed consent
* Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile

Exclusion Criteria

* Co-infection of Hepatitis B Virus (HBV), human immunodeficiency virus (HIV) or any HCV genotype other than subgenotype 1b
* 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