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

Mallinckrodt

Status and phase: Withdrawn; Phase 3

Conditions: Hepatic Encephalopathy

Treatments: Drug: Placebo; Drug: MNK-6105; Drug: Standard of Care

Study type: Interventional

Funder types: Industry

Identifiers

NCT04128462

MNK61053106

2019-001635-31 (EudraCT Number)

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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0 participants in 2 patient groups, including a placebo group

MNK6105 + SoC

Experimental group

Description:

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

Treatment:

Drug: Standard of Care

Drug: MNK-6105

Placebo + SoC

Placebo Comparator group

Description:

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

Treatment:

Drug: Standard of Care

Drug: Placebo