Phase 2 Completed N=50 Randomized Treatment

MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)

Cirrhosis · Hepatic Encephalopathy (HE)

Source: ClinicalTrials.gov NCT03712280 ↗

Enrolled (actual)

Serious AEs

4.2%

Results posted

Jul 2021

Primary outcomePrimary: Ammonia Plasma Levels at Baseline and Day 5 — 70.4; 91.4; 92.6; 78.1 μmol/L

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.

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	—

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

View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.