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Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04128462

Enrollment

Registered

2019-10-16

Start date

2021-11-30

Completion date

2025-07-31

Last updated

2021-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatic Encephalopathy

Keywords

Overt HE diagnosis

Brief 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.

Interventions

DRUGMNK-6105

L-Ornithine Phenylacetate for IV infusion

DRUGPlacebo

Matching placebo for IV infusion

DRUGStandard of Care

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of patients with a clinical response at Day 5	at Day 5 (within 36 months)

Secondary

Measure	Time frame
Number of patients discharged 30 days after end of treatment.	at Day 35 (within 36 months)
Number of patients readmitted to the hospital due to overt hepatic encephalopathy (OHE) 30 days after discharge.	30 days after discharge (within 36 months)
Number of patients with adverse events or deaths during the study	within 36 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026