drugset / Trial / NCT04128462
MNK-6105 for Patients With Cirrhosis and High Ammonia Levels Affecting Brain Function
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2021-11
- Primary completion
- 2025-04
- Completion
- 2025-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | MNK-6105 | Unknown | 15 g | Intravenous |
| Background | Lactulose | Other / unclassified | — | — |
| Background | Rifaximin | Other / unclassified | — | — |