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

Hepatic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04128462
• Other study ID #: MNK61053106
• Secondary ID: 2019-001635-31
• Status: Withdrawn
• Phase: Phase 3
• Start date: November 2021
• Est. completion date: July 2025

Study information

• Verified date: September 2021
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2025
• Est. primary completion date: April 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Drug:
• MNK-6105
L-Ornithine Phenylacetate for IV infusion
• Placebo
Matching placebo for IV infusion
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients with a clinical response at Day 5		at Day 5 (within 36 months)
Secondary	Number of patients discharged 30 days after end of treatment.		at Day 35 (within 36 months)
Secondary	Number of patients readmitted to the hospital due to overt hepatic encephalopathy (OHE) 30 days after discharge.		30 days after discharge (within 36 months)
Secondary	Number of patients with adverse events or deaths during the study		within 36 months