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

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.

Inclusion Criteria:

To be included, a patient must:

• Be the age of majority in their country (considered an adult)
• Be male or non-pregnant, non-lactating female
• Have OHE (Stage 2, 3, or 4) as a complication of cirrhosis
• Have been hospitalized within 24 hours before start of infusion (SOI)
• Receive at least 6 hours of SoC treatment

Exclusion Criteria:

Patients will be excluded if they have inadequate renal function or any other disease, laboratory value, or condition (including allergy, drug use or treatments) that per protocol or in the opinion of the investigator, might increase the risk of compromising:

1. health or well-being of the patient
2. safety of study staff
3. analysis of results