Trials / Completed
CompletedNCT01854697
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
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)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 311 (actual)
- Sponsor
- AbbVie · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
The primary purpose of this study is to demonstrate that treatment with ABT-450/ritonavir (r)/ABT-267 and ABT-333 administered with or without ribavirin (RBV) has non-inferior efficacy compared to treatment with telaprevir and pegylated interferon alpha-2a (pegIFN) and RBV and to compare the safety of these regimens in treatment-naive hepatitis C virus (HCV) genotype (GT) 1a- and 1b-infected adults.
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 | Telaprevir | Film-coated tablet |
| DRUG | Pegylated Interferon alpha 2-a (PegIFN) | Pre-filled syringe |
Timeline
- Start date
- 2013-03-01
- Primary completion
- 2014-11-01
- Completion
- 2015-07-01
- First posted
- 2013-05-15
- Last updated
- 2018-06-06
- Results posted
- 2016-02-22
Source: ClinicalTrials.gov record NCT01854697. Inclusion in this directory is not an endorsement.