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A Study to Evaluate the Safety and Efficacy of Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir With or Without Ribavirin in US Veterans With Genotype 1 Chronic Hepatitis C Virus Infection

NCT ID: NCT02442284

Last Updated: 2017-10-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-13

Study Completion Date

2016-10-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir with or without ribavirin in US veterans with genotype 1 chronic hepatitis C virus infection.

Detailed Description

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Conditions

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Chronic Hepatitis C Cirrhosis Hepatitis C Virus

Keywords

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Chronic Hepatitis C Interferon-Free Hepatitis C Genotype 1 Hepatitis C Virus Hepatitis C 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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3-DAA ± RBV for 12 or 24 weeks

3-DAA (ombitasvir/paritaprevir/ritonavir \[25 mg/150 mg/100 mg once daily\] and dasabuvir \[250 mg twice daily\]) with or without weight-based ribavirin (± RBV; dosed 1,000 or 1,200 mg daily divided twice a day) for 12 or 24 weeks, dosed as per label based on genotype and presence of cirrhosis.

Group Type EXPERIMENTAL

ombitasvir/paritaprevir/ritonavir and dasabuvir

Intervention Type DRUG

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Ribavirin

Intervention Type DRUG

Tablet

Interventions

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ombitasvir/paritaprevir/ritonavir and dasabuvir

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

Intervention Type DRUG

Ribavirin

Tablet

Intervention Type DRUG

Other Intervention Names

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

Eligibility Criteria

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Inclusion Criteria

* US military veteran currently receiving healthcare through the Veterans Health Administration
* Screening laboratory result indicating hepatitis C virus (HCV), genotype 1-infection
* Positive for hepatitis C antibodies or HCV RNA at least 6 months before Screening, and HCV RNA \> 1,000 IU/mL at the time of Screening or HCV RNA \> 1,000 IU/mL at the time of Screening with a liver biopsy consistent with chronic HCV-infection (or a liver biopsy performed prior to enrollment with evidence of chronic hepatitis C disease)

Exclusion Criteria

* Women who are pregnant or breastfeeding
* Positive test result for hepatitis B surface antigen (HbsAg) or anti-HIV antibodies (HIV Ab)
* Prior or current use of any investigational or commercially available anti-HCV agents other than IFN, pegIFN, RBV or sofosbuvir
* Any current or past clinical evidence of Child-Pugh B or C classification
* Confirmed presence of hepatocellular carcinoma indicated on imaging techniques within 3 months prior to Screening or on an ultrasound performed at Screening for participants with cirrhosis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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AbbVie Inc.

Role: STUDY_DIRECTOR

AbbVie

Countries

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Puerto Rico United States

Related Links

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http://rxabbvie.com

Related Info

Other Identifiers

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M14-251

Identifier Type: -

Identifier Source: org_study_id