NCT04128462

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

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

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Mallinckrodt · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatic Encephalopathy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-11-01
• Primary completion: 2025-04-01
• Completion: 2025-07-01
• First posted: 2019-10-16
• Last updated: 2021-09-22

Regulatory

• FDA-regulated drug study