A Study to Evaluate Chronic Hepatitis C Infection

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

636 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-10-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of ABT-450, ritonavir and ABT-267 (ABT-450/r/ABT-267; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) co-administered with ribavirin (RBV) in hepatitis C virus genotype 1 infected treatment-naïve adults.

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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

DOUBLE

Participants Investigators

Study Groups

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ABT-450/r/ABT-267 and ABT-333, plus RBV

Double-blind ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based ribavirin (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Group Type EXPERIMENTAL

ABT-450/r/ABT-267, ABT-333

Intervention Type DRUG

ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Ribavirin

Intervention Type DRUG

Capsule (double-blind treatment period), tablet (open-label treatment period)

Placebo Followed by ABT-450/r/ABT-267 and ABT-333, plus RBV

Double-blind placebo for 12 weeks, followed by open-label ABT-450/r/ABT-267 (150 mg/100 mg/25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based RBV (RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 weeks

Group Type EXPERIMENTAL

ABT-450/r/ABT-267, ABT-333

Intervention Type DRUG

ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Ribavirin

Intervention Type DRUG

Capsule (double-blind treatment period), tablet (open-label treatment period)

Placebo for ABT-450/r/ABT-267

Intervention Type DRUG

Tablet

Placebo for ABT-333

Intervention Type DRUG

Tablet

Placebo for ribavirin

Intervention Type DRUG

Capsule

Interventions

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ABT-450/r/ABT-267, ABT-333

ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet

Intervention Type DRUG

Ribavirin

Capsule (double-blind treatment period), tablet (open-label treatment period)

Intervention Type DRUG

Placebo for ABT-450/r/ABT-267

Tablet

Intervention Type DRUG

Placebo for ABT-333

Tablet

Intervention Type DRUG

Placebo for ribavirin

Capsule

Intervention Type DRUG

Other Intervention Names

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ABT-267 also known as ombitasvir ABT-450 also known as paritaprevir ABT-333 also known as dasabuvir Viekira PAK

Eligibility Criteria

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Inclusion Criteria

* Females must be post-menopausal for at least 2 years or surgically sterile or practicing specific forms of birth control
* Chronic hepatitis C, genotype 1-infection and HCV RNA level greater than 10,000 IU/mL at screening
* Subject has never received antiviral treatment for hepatitis C infection
* No evidence of liver cirrhosis

Exclusion Criteria

* Positive screen for drugs or alcohol
* Significant sensitivity to any drug
* Use of contraindicated medications within 2 weeks of dosing
* Certain predefined abnormal laboratory tests
* Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No