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

Mallinckrodt

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Hepatic Encephalopathy

Interventions

MNK-6105DRUG

L-Ornithine Phenylacetate for IV infusion

PlaceboDRUG

Matching placebo for IV infusion

Standard of CareDRUG

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Number of patients with a clinical response at Day 5

Time frame: at Day 5 (within 36 months)

Secondary Outcomes

Number of patients discharged 30 days after end of treatment.

Time frame: at Day 35 (within 36 months)

Number of patients readmitted to the hospital due to overt hepatic encephalopathy (OHE) 30 days after discharge.

Time frame: 30 days after discharge (within 36 months)

Number of patients with adverse events or deaths during the study

Time frame: within 36 months

Data from ClinicalTrials.gov

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