At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 311 enrolled
Drug / intervention
ABT-450/r/ABT-267, ABT-333 +3 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.
A Randomized, Open-Label Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered With and Without Ribavirin Compared to Telaprevir Co-administered With Pegylated Interferon α-2a and Ribavirin in Treatment-Naïve Adults With Chronic Hepatitis C Genotype 1 Virus Infection (MALACHITE I)
In Brief
A Phase 3 clinical trial evaluating ABT-450/r/ABT-267, ABT-333, Ribavirin, and 2 other interventions for Chronic Hepatitis C Infection. Completed, enrolled 311 participants.
Detailed Summary
This is a study to evaluate the efficacy and safety of three experimental drugs compared with telaprevir (a licensed product) in people with hepatitis C virus infection who have not had treatment before.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C Infection
Countries--
Collaborators--
Timeline
Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2013
First PostedMay 2013
Primary CompletionNov 2014
Study CompletionJul 2015
TodayJul 2026
First PostedMay 15, 2013
Enrollment StartMar 1, 2013
Primary CompletionNov 1, 2014
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 13.1 years ago
Interventions
ABT-450/r/ABT-267, ABT-333drug
Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet
Ribavirindrug
Tablet
Telaprevirdrug
Film-coated tablet
Pegylated Interferon alpha 2-a (PegIFN)drug
Pre-filled syringe