Who is sponsoring MALACHITE 1?

MALACHITE 1 is sponsored by AbbVie.

What condition does MALACHITE 1 study?

MALACHITE 1 studies Chronic Hepatitis C Infection.

What drugs are being tested in MALACHITE 1?

Interventions: ABT-450/r/ABT-267, ABT-333, Ribavirin, Telaprevir, Pegylated Interferon alpha 2-a (PegIFN).

What is the status of MALACHITE 1?

MALACHITE 1 is currently COMPLETED.

Last reviewed 2018-05-02 · How we verify

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) (MALACHITE 1)

NCT01854697 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	AbbVie
Phase	Phase 3
Status	COMPLETED
Enrolment	311
Start date	2013-03
Completion	2015-07

Conditions

Chronic Hepatitis C Infection

Interventions

ABT-450/r/ABT-267, ABT-333
Ribavirin
Telaprevir
Pegylated Interferon alpha 2-a (PegIFN)

Primary outcomes

Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses — 12 weeks after the last actual dose of active study drug
The percentage of participants with sustained virologic response (plasma Hepatitis C virus ribonucleic acid \[HCV RNA\] level less than the lower limit of quantitation \[\< LLOQ\]) 12 weeks after the last dose of study drug.