At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 222 enrolled
Drug / intervention
ombitasvir/paritaprevir/ritonavir and dasabuvir +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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)
In Brief
A Phase 3 clinical trial evaluating ombitasvir/paritaprevir/ritonavir and dasabuvir and ribavirin for Chronic Hepatitis C Infection. Completed, enrolled 222 participants.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C Infection
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartApr 2015
First PostedMay 2015
Primary CompletionJul 2016
Study CompletionSep 2016
TodayJul 2026
First PostedMay 13, 2015
Enrollment StartApr 27, 2015
Primary CompletionJul 4, 2016
Study CompletionSep 26, 2016
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 11.1 years ago
Interventions
ombitasvir/paritaprevir/ritonavir and dasabuvirdrug
Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
ribavirindrug
Tablet