Trials / Completed
CompletedNCT01854528
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) for Treatment of Chronic Hepatitis C Infection in Treatment-experienced Adults
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 148 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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).
Detailed description
A randomized, open-label, parallel-arm, multicenter study to evaluate the safety and antiviral activity of the 3-DAA regimen (ABT-450/ritonavir/ABT-267 \[ABT-450/r/ABT-267\] and ABT-333) plus ribavirin (3-DAA/RBV) compared with the combination of telaprevir (TPV) with RBV and pegIFN (TPV/RBV) in noncirrhotic participants with chronic hepatitis C virus genotype 1 (HCV GT1) infection who were previously treated with pegylated interferon/ribavirin (pegIFN/RBV). Participants were randomized in a 2:1 ratio to receive 3-DAA/RBV (ABT-450/r/ABT-267 and ABT-333 plus RBV for 12 weeks) or TPV/RBV (TPV co-administered with pegIFN and RBV for 12 weeks, followed by followed by pegIFN and RBV for either 12 or 36 weeks, per local prescribing information).
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ABT-450/r/ABT-267, ABT-333 | Tablet; ABT-450 coformulated with ritonavir and ABT-267, ABT-333 tablet |
| DRUG | Ribavirin | Tablet |
| DRUG | Pegylated Interferon a-2a (PegINF) | Pre-filled syringe |
| DRUG | Telaprevir | Film-coated tablet |
Timeline
- Start date
- 2013-06-01
- Primary completion
- 2014-11-01
- Completion
- 2015-07-01
- First posted
- 2013-05-15
- Last updated
- 2018-06-06
- Results posted
- 2016-02-11
Source: ClinicalTrials.gov record NCT01854528. Inclusion in this directory is not an endorsement.