A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Tolerability of MNK6105 (an Intravenous Formulation of L-Ornithine Phenylacetate) in Hospitalized Patients With Cirrhosis and Hyperammonemia Associated With an Episode of Hepatic Encephalopathy
Latest Information Update: 23 Sep 2021
At a glance
- Drugs Ornithine phenylacetate (Primary) ; Lactulose; Rifaximin
- Indications Hepatic encephalopathy
- Focus Registrational; Therapeutic Use
- Sponsors Mallinckrodt Inc.
- 16 Sep 2021 Status changed from not yet recruiting to withdrawn prior to enrolment due to business decision.
- 16 Apr 2021 Planned End Date changed from 1 Dec 2022 to 1 Jul 2025.
- 16 Apr 2021 Planned primary completion date changed from 1 Nov 2022 to 1 Apr 2025.