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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

NCT02442271 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 222

Last updated 2017-08-01

Study results available
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Summary

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.

Conditions

  • Chronic Hepatitis C Infection

Interventions

DRUG

ombitasvir/paritaprevir/ritonavir and dasabuvir

Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet

DRUG

ribavirin

Tablet

Sponsors & Collaborators

Principal Investigators

  • AbbVie Inc · AbbVie

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-27
Primary Completion
2016-07-04
Completion
2016-09-26

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02442271 on ClinicalTrials.gov