drugset / Trial / NCT04128462

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

NCT04128462

Phase 3 Withdrawn Mallinckrodt
RandomizedParallel-groupDouble-blindTreatment

Summary

This study is for patients with cirrhosis and hepatic encephalopathy who are in the hospital. This means they have a high ammonia level which is affecting their brain function. All patients will receive the standard of (regular) care. Each will have an equal chance (like flipping a coin) of receiving the experimental drug or placebo along with the standard care. Each patient will have tests during the first 24 hours, receive treatment for up to 5 days, and have 30 days of follow-up.

Timeline

Start
2021-11
Primary completion
2025-04
Completion
2025-07

Drugs

EvaluationDrugModalityDoseRoute
Subject MNK-6105 Unknown 15 g Intravenous
Background Lactulose Other / unclassified
Background Rifaximin Other / unclassified