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A Study to Evaluate Paritaprevir With Ritonavir (ABT-450/r) When Given Together With Ombitasvir and With and Without Ribavirin (RBV) in Treatment-Naïve Participants With Genotype 1, 2 or 3 Chronic Hepatitis C Virus (HCV)

NCT ID: NCT01458535

Last Updated: 2016-07-11

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

61 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2013-05-31

Brief Summary

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The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve participants with genotype 1, 2 or 3 chronic HCV infection.

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Detailed Description

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This was a 2 sequential arm, combination treatment study where each arm contained 3 cohorts: one each for HCV genotype 1, 2, and 3. The study consisted of 2 phases, a treatment phase and a post-treatment phase. The treatment phase was designed to explore the antiviral activity, safety and pharmacokinetics of ABT-450/r dosed in combination with ABT-267 with and without RBV for up to 12 weeks. The post-treatment phase was designed to monitor and evaluate Sustained Virologic Response (SVR) 12, SVR 24, and the evolution and persistence of viral resistance to ABT-267 and ABT-450 in HCV genotype 1-, 2-, and 3-infected participants who have been exposed to ABT-267 and ABT-450/r. Arms 1 and 2 were enrolled sequentially.

Conditions

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Hepatitis C Virus

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ABT-450/r and ABT-267 plus RBV in genotype 1 participants

ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve participants with HCV genotype 1 infection.

Group Type EXPERIMENTAL

ABT-450

Intervention Type DRUG

tablets

ABT-267

Intervention Type DRUG

tablets

ribavirin

Intervention Type DRUG

tablets

ritonavir

Intervention Type DRUG

capsules

ABT-450/r and ABT-267 plus RBV in genotype 2 participants

ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 2 infection.

Group Type EXPERIMENTAL

ABT-450

Intervention Type DRUG

tablets

ABT-267

Intervention Type DRUG

tablets

ribavirin

Intervention Type DRUG

tablets

ritonavir

Intervention Type DRUG

capsules

ABT-450/r and ABT-267 plus RBV in genotype 3 participants

ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 3 infection.

Group Type EXPERIMENTAL

ABT-450

Intervention Type DRUG

tablets

ABT-267

Intervention Type DRUG

tablets

ribavirin

Intervention Type DRUG

tablets

ritonavir

Intervention Type DRUG

capsules

ABT-450/r and ABT-267 in genotype 1 participants

ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 1 infection.

Group Type EXPERIMENTAL

ABT-450

Intervention Type DRUG

tablets

ABT-267

Intervention Type DRUG

tablets

ritonavir

Intervention Type DRUG

capsules

ABT-450/r and ABT-267 in genotype 2 participants

ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 2 infection.

Group Type EXPERIMENTAL

ABT-450

Intervention Type DRUG

tablets

ABT-267

Intervention Type DRUG

tablets

ritonavir

Intervention Type DRUG

capsules

ABT-450/r and ABT-267 in genotype 3 participants

ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 3 infection.

Group Type EXPERIMENTAL

ABT-450

Intervention Type DRUG

tablets

ABT-267

Intervention Type DRUG

tablets

ritonavir

Intervention Type DRUG

capsules

Interventions

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ABT-450

tablets

Intervention Type DRUG

ABT-267

tablets

Intervention Type DRUG

ribavirin

tablets

Intervention Type DRUG

ritonavir

capsules

Intervention Type DRUG

Other Intervention Names

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paritaprevir ombitasvir Norvir

Eligibility Criteria

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Inclusion Criteria

* Participants who had a body mass index 18 to \< 35 kg/m\^2.
* Females were either postmenopausal for at least 2 years, surgically sterile, or willing to use at least 2 effective forms of birth control.
* Males must have been surgically sterile or agreed to use at least 2 effective forms of birth control throughout the course of the study.
* Participants were in a condition of general good health, other than the HCV infection.
* Participants had a chronic HCV genotype 1, 2, or 3 infection for at least 6 months, a plasma HCV RNA \> 50,000 IU/mL, and FibroTest score \<= 0.72 and aspartate aminotransferase (AST) to platelet ratio index \<= 2, Fibroscan® result of \< 9.6 kilopascal (kPa), or absence of cirrhosis based on a liver biopsy.

Exclusion Criteria

* Positive drug screen
* Previous use of anti-HCV agents
* History of cardiac disease
* History of uncontrolled diabetes or diabetes requiring insulin
* Abnormal laboratory results
* Females who were pregnant or planned to become pregnant within 6 months after their last dose of study drug/RBV or were breastfeeding; males whose partners were pregnant or would become pregnant within 6 months after their last dose of study drug/RBV
* Positive test result for hepatitis B surface antigen (HBsAg) or anti-human immunodeficiency virus (HIV) antibody (Ab). Negative HIV status was to be confirmed at screening.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Andrew Campbell, MD

Role: STUDY_DIRECTOR

AbbVie

Related Links

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http://www.rxabbvie.com/

Related Info

Other Identifiers

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M12-998

Identifier Type: -

Identifier Source: org_study_id

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