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Completed

NCT Number: NCT03712280

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

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.

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Key information

Conditions

Hepatic Cirrhosis Brain Diseases Brain Diseases, Metabolic Central Nervous System Diseases Digestive System Diseases Fibrosis Hepatic Encephalopathy Hepatic Encephalopathy (HE) Hepatic Insufficiency Liver Cirrhosis Liver Diseases Liver Failure Metabolic Diseases Nervous System Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fundacion de Investigacion (Research Foundation), San Juan, Puerto Rico

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MNK6106

Drug

1 gram tablet of MNK6106 for oral administration

Other names: Study Drug, L-Ornithine Phenylacetate

Rifaximin

Drug

550 mg tablet of rifaximin for oral administration

Other names: Xifaxan

Primary outcomes

  1. Ammonia Plasma Levels at Baseline and Day 5

    Time frame: Baseline, Day 5

    This test measures the level of ammonia in your blood. Ammonia, also known as NH3, is a waste product made by your body during the digestion of protein. Normally, ammonia is processed in the liver, where it is changed into another waste product called urea. Urea is passed from the body in urine.

    If your body cannot process or eliminate ammonia, a lab test of a blood sample shows it has built up in the bloodstream. High ammonia levels in the blood can lead to serious health problems, including hepatic encephalopathy.

Secondary outcomes

  1. Number of Participants With Adverse Events by the End of the Trial

    Time frame: within 15 days

    End of trial is defined as 7 (+/-3) days after last study treatment

Sponsors and collaborators

Lead sponsor

Mallinckrodt

Industry

Registry information

Official study title

A Randomized, Open-Label, Phase 2a Comparator Study to Assess the Pharmacodynamics, Safety and Pharmacokinetics of Oral Administration MNK6106 (L-Ornithine Phenylacetate) Versus Rifaximin in Subjects With Hepatic Cirrhosis and a History of Prior Episodes of Hepatic Encephalopathy

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Oct 19, 2018
Registry last updated
Jul 20, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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