CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 148 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.

Search/NCT01854528
NCT01854528Phase 3Completed
CompareCT.gov

A Randomized, Open-Labeled Study to Evaluate the Efficacy and Safety of ABT-450/Ritonavir/ABT-267 and ABT-333 Co-administered With Ribavirin Compared to Telaprevir Co-administered With Pegylated Interferon a-2a and Ribavirin in Treatment-Experienced Adults With Chronic Hepatitis C Genotype 1 Virus Infection (MALACHITE-II)

AbbVie·interventional·Posted May 15, 2013·Updated Jun 6, 2018

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 148 participants.

Detailed Summary

The purpose of this study is to evaluate the safety and antiviral activity of 3 direct-acting antiviral agents (DAAs; ABT-450/ritonavir/ABT-267 \[ABT-450/r/ABT-267; ABT-267 also known as ombitasvir\] and ABT-333 \[also known as dasabuvir\]) plus ribavirin (RBV) compared with telaprevir (TPV) with pegylated interferon/ribavirin (pegIFN/RBV) in patients with chronic hepatitis C virus genotype 1 (HCV GT1) infection without cirrhosis who were previously treated with pegylated interferon/ribavirin (pegIFN/RBV).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsChronic Hepatitis C Infection
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedMay 15, 2013
Enrollment StartJun 1, 2013
Primary CompletionNov 1, 2014
Study CompletionJul 1, 2015
TodayJul 2, 2026
Enrollment to primary: 1.4 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

Pegylated Interferon a-2a (PegINF)drug

Pre-filled syringe

Telaprevirdrug

Film-coated tablet