Status:
WITHDRAWN
MNK-6105 for Patients With Cirrhosis and High Ammonia Levels Affecting Brain Function
Lead Sponsor:
Mallinckrodt
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 rece...
Eligibility Criteria
Inclusion
- 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
- 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:
- health or well-being of the patient
- safety of study staff
- analysis of results
Key Trial Info
Start Date :
November 1 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2025
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04128462
Start Date
November 1 2021
End Date
July 1 2025
Last Update
September 22 2021
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