Trials / Completed
CompletedNCT02442271
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
An Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ombitasvir/ABT-450/Ritonavir and Dasabuvir With or Without Ribavirin (RBV) in Treatment-Naïve or Treatment-Experienced Adults in Brazil With Genotype 1 Chronic Hepatitis C Virus (HCV) Infection (TOPAZ III)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 222 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ombitasvir/paritaprevir/ritonavir and dasabuvir | Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet |
| DRUG | ribavirin | Tablet |
Timeline
- Start date
- 2015-04-27
- Primary completion
- 2016-07-04
- Completion
- 2016-09-26
- First posted
- 2015-05-13
- Last updated
- 2017-08-01
- Results posted
- 2017-08-01
Source: ClinicalTrials.gov record NCT02442271. Inclusion in this directory is not an endorsement.