CompletedPhase 2

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

United States, Puerto Rico50 participantsStarted 2018-12-01

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. 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

What they're measuring

Ammonia Plasma Levels at Baseline and Day 5

Timeframe: Baseline, Day 5

Trial details

NCT IDNCT03712280

SponsorMallinckrodt

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-07-14

Results submitted2021-06-29

View on ClinicalTrials.gov More Hepatic Cirrhosis trials