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MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

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

NCT03712280•Mallinckrodt

View on ClinicalTrials.gov

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

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•A potential participant may only be included if (at screening), he/she:
•1. Understands the study and has signed informed consent
•2. Is an adult, not pregnant or lactating
•3. Has cirrhosis of the liver
•4. Has had 1 instance of HE within 12 months
•5. Has hyperammonaemia defined as ≥37 μmol/L at screening

Exclusion Criteria

•A potential participant will be excluded if (at screening), he/she:
•1. Has contraindicated allergies
•2. Expects liver transplant within 1 month
•3. Has had a liver shunt within the last 3 months
•4. Has inadequate kidney, gastrointestinal, or cardiac function
•5. Has cancer, infection, lab abnormalities, or any other condition that, per protocol or in the opinion of the investigator might compromise:
•1. the safety and well-being of the participant or potential offspring
•2. the safety of study staff
•3. the analysis of results

Locations (5)

Southern California Research Center

Coronado, California, United States

Inland Empire Clinical Trials

Rialto, California, United States

Global Clinical Professionals

St. Petersburg, Florida, United States

American Research Corporation at the Texas Liver Institute

San Antonio, Texas, United States

Fundacion de Investigacion (Research Foundation)

San Juan, Puerto Rico

Key Dates

Start Date

December 1, 2018

Primary Completion Date

July 14, 2020

Completion Date

July 14, 2020

Last Updated

July 20, 2021

Enrollment

ACTUAL participants

Conditions

Hepatic CirrhosisHepatic Encephalopathy (HE)

Interventions

MNK6106

DRUG

Rifaximin

DRUG

7.0T Magnetic Resonance Imaging Study for Hepatic Encephalopathy

NCT06923254

Hepatic Encephalopathy (HE)MRI+1 more

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NOT_YET_RECRUITING

Evaluation of the Efficacy and Safety of Portal Pressure Gradient (PPG) Measurement Guided by Endoscopic Ultrasound (EUS) in the Therapeutic Algorithm of Patients with Liver Cirrhosis.

NCT06664307

Portal Pressure Gradient (PPG) Measurement Guided by Endoscopic Ultrasound (EUS)Hepatic Cirrhosis

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 20, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

7.0T Magnetic Resonance Imaging Study for Hepatic Encephalopathy

Evaluation of the Efficacy and Safety of Portal Pressure Gradient (PPG) Measurement Guided by Endoscopic Ultrasound (EUS) in the Therapeutic Algorithm of Patients with Liver Cirrhosis.

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