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

NCT ID: NCT04128462

Last Updated: 2021-09-22

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-11-30
• Study Completion Date: 2025-07-31

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.

Conditions

Hepatic Encephalopathy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

MNK6105 + SoC

Participants will receive standard of care (SoC), along with MNK-6105 delivered by continuous intravenous (IV) infusion as follows:

• Loading dose: 20 g infused over 6 hours
• Intermediate dose: 15 g infused over 18 hours
• Maintenance dose: 15 g infused over 24 hours for up to 4 days

Group Type: EXPERIMENTAL

MNK-6105

Intervention Type: DRUG

L-Ornithine Phenylacetate for IV infusion

Standard of Care

Intervention Type: DRUG

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

Placebo + SoC

Participants will receive SoC, along with continuous IV infusion of matching placebo for 5 days.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Matching placebo for IV infusion

Standard of Care

Intervention Type: DRUG

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

Interventions

MNK-6105

L-Ornithine Phenylacetate for IV infusion

Intervention Type: DRUG

Placebo

Matching placebo for IV infusion

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

L-Ornithine Phenylacetate; Matching Placebo; SoC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mallinckrodt

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Team Leader

Role: STUDY_DIRECTOR

Mallinckrodt

Other Identifiers

2019-001635-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MNK61053106

Identifier Type: -

Identifier Source: org_study_id