A Study to Evaluate the Safety and Effect of the Experimental Drugs ABT-450/Ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 in Subjects With Chronic Hepatitis C

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

187 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2014-10-31

Brief Summary

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The purpose of this study is to evaluate the safety and antiviral activity of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267; ABT-450 also known as paritaprevir; ABT-267 also known as ombitasvir) and ABT-333 (also known as dasabuvir) with and without ribavirin (RBV) in patients with chronic hepatitis C virus genotype 1b (HCV GT1b) infection without cirrhosis.

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Detailed Description

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A randomized, open-label, multicenter study to evaluate the safety and antiviral activity of the combination of ABT-450/ritonavir/ABT-267 (ABT-450/r/ABT-267) and ABT-333 with and without ribavirin (RBV) in treatment-experienced, noncirrhotic participants with chronic hepatitis C virus genotype 1b (HCV GT1b) infection.

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

NONE

Study Groups

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

ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily), plus weight-based 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

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

Ribavirin

Intervention Type DRUG

Tablet

ABT-450/r/ABT-267 and ABT-333

ABT-450/r/ABT-267 (150 mg/ 100 mg/ 25 mg once daily) and ABT-333 (250 mg twice daily) for 12 weeks

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

Ribavirin

Tablet

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* Females must be practicing specific forms of birth control on study treatment, or be post-menopausal for more than 2 years or surgically sterile
* Chronic hepatitis C, genotype 1b-infection (HCV RNA level greater than or equal to 10,000 IU/mL at screening)
* Subject's hepatitis C virus genotype is subgenotype 1b at Screening without co infection with any other genotype/subgenotype.

Exclusion Criteria

* Significant liver disease with any cause other than HCV as the primary cause
* Positive hepatitis B surface antigen or anti-human immunodeficiency virus antibody
* Positive screen for drugs or alcohol
* Use of contraindicated medications within 2 weeks of dosing

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No