Phase 2
N=50
MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
Hepatic Cirrhosis · Hepatic Encephalopathy (HE)
Bottom Line
View on ClinicalTrials.gov: NCT03712280 ↗Enrolled (actual)
50
Serious AEs
4.2%
Results posted
Jul 2021
Primary outcome: Primary: Ammonia Plasma Levels at Baseline and Day 5 — 70.4; 91.4; 92.6; 78.1 μmol/L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MNK6106 (Drug); Rifaximin (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mallinckrodt
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ammonia Plasma Levels at Baseline and Day 5 |
70.4; 91.4; 92.6; 78.1; 72.7; 63.9 | — |
| SECONDARY Number of Participants With Adverse Events by the End of the Trial |
0; 0; 2; 0; 5; 6 | — |
Summary
The main reason for this study is to see how the study drug interacts with the body.
It will compare different doses of the study drug with a drug already in use.
Participants will be adults with liver disease that has affected the brain in the past.
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
Data sourced from ClinicalTrials.gov (NCT03712280). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.