MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
Hepatic Cirrhosis, Hepatic Encephalopathy (HE)
About this trial
This is an interventional treatment trial for Hepatic Cirrhosis
Eligibility Criteria
Key Inclusion Criteria:
A potential participant may only be included if (at screening), he/she:
- Understands the study and has signed informed consent
- Is an adult, not pregnant or lactating
- Has cirrhosis of the liver
- Has had 1 instance of HE within 12 months
- Has hyperammonaemia defined as ≥37 μmol/L at screening
Key Exclusion Criteria:
A potential participant will be excluded if (at screening), he/she:
- Has contraindicated allergies
- Expects liver transplant within 1 month
- Has had a liver shunt within the last 3 months
- Has inadequate kidney, gastrointestinal, or cardiac function
Has cancer, infection, lab abnormalities, or any other condition that, per protocol or in the opinion of the investigator might compromise:
- the safety and well-being of the participant or potential offspring
- the safety of study staff
- the analysis of results
Sites / Locations
- Southern California Research Center
- Inland Empire Clinical Trials
- Global Clinical Professionals
- American Research Corporation at the Texas Liver Institute
- Fundacion de Investigacion (Research Foundation)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Experimental
Experimental
Active Comparator
Group A: MNK6106 2 grams (tid)
Group B: MNK6106 4 grams (bid)
Group C: MNK6106 4 grams (tid)
Group D: Rifaximin 550 mg (bid)
Participants receive 2 tablets of MNK6106 three times daily (tid) for 5 days
Participants receive 4 tablets of MNK6106 twice daily (bid) for 5 days
Participants receive 4 tablets of MNK6106 tid for 5 days
Participants receive 1 tablet of rifaximin bid for 5 days