MNK-6105 for Patients With Cirrhosis and High Ammonia Levels Affecting Brain Function

PHASE3WithdrawnINTERVENTIONAL
0
Timeline

Start Date

November 30, 2021

Primary Completion Date

April 30, 2025

Study Completion Date

July 31, 2025

Conditions
Hepatic Encephalopathy
Interventions
DRUG

MNK-6105

L-Ornithine Phenylacetate for IV infusion

DRUG

Placebo

Matching placebo for IV infusion

DRUG

Standard of Care

Lactulose ± rifaximin as SoC treatment for overt HE should be administered per the clinical judgement of the investigator and usual institutional practice.

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Mallinckrodt

INDUSTRY