A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs in Adults With Hepatitis C Virus Infection, Who Are Either Treatment-naive or Treatment-experienced in Brazil

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

222 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-27

Study Completion Date

2016-09-26

Brief Summary

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The purpose of this study is to evaluate the proportion of subjects achieving sustained virologic response 12 weeks post-treatment (SVR12) in adults with genotype 1 (GT1) chronic HCV infection, who received treatment with 3 direct-acting antiviral agents (3-DAAs; ombitasvir/paritaprevir/ritonavir and dasabuvir) with or without ribavirin.

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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

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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3-DAA ± RBV

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.

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

* Females must be post-menopausal for more than 2 years or surgically sterile or practicing acceptable forms of birth control
* Males must be surgically sterile or agree to practice acceptable forms of birth control
* Chronic hepatitis C virus (HCV) infection at screening
* Fibrosis stage F3 or greater, documented by acceptable tests
* Participants with cirrhosis: Absence of hepatocellular carcinoma (HCC) as indicated by acceptable methods

Exclusion Criteria

* Women who are pregnant or breastfeeding
* Positive test result for Hepatitis B surface antigen (HbsAg) or anti-HIV antibody positive (HIV Ab)
* Use of contraindicated medications within 2 weeks of dosing
* Clinically significant abnormalities or co-morbidities
* History of solid organ transplant
* Abnormal laboratory tests
* Current or past clinical evidence of Child-Pugh B or C classification or clinical history of liver decompensation

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No