At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 105 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/Paritaprevir/Ritonavir and Dasabuvir With Low-Dose Ribavirin QD in Subjects With Genotype 1a Chronic Hepatitis C Virus Infection (GEODE II)
In Brief
A Phase 3 clinical trial evaluating ombitasvir/paritaprevir/ritonavir and dasabuvir and ribavirin for Hepatitis C Virus (HCV). Completed, enrolled 105 participants.
Detailed Summary
This study seeks to assess the safety and efficacy of treatment with ombitasvir/paritaprevir/ritonavir and dasabuvir with low-dose ribavirin in non-cirrhotic, genotype 1a (GT1a) hepatitis C virus infected participants who are treatment-naïve or treatment-experienced with Interferon (IFN) or Pegylated Interferon (pegIFN) with or without Ribavirin (RBV).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus (HCV)
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartOct 2015
First PostedNov 2015
Primary CompletionOct 2016
Study CompletionDec 2016
TodayJul 2026
First PostedNov 20, 2015
Enrollment StartOct 28, 2015
Primary CompletionOct 7, 2016
Study CompletionDec 28, 2016
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 10.6 years ago
Interventions
ombitasvir/paritaprevir/ritonavir and dasabuvirdrug
Tablet; ombitasvir coformulated with paritaprevir and ritonavir, dasabuvir tablet
ribavirindrug
Tablet