- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03712280
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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San Juan, Puerto Rico, 00927
- Fundacion de Investigacion (Research Foundation)
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California
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Coronado, California, United States, 92118
- Southern California Research Center
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Rialto, California, United States, 92377
- Inland Empire Clinical Trials
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Florida
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Saint Petersburg, Florida, United States, 33702
- Global Clinical Professionals
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Texas
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San Antonio, Texas, United States, 78215
- American Research Corporation at The Texas Liver Institute
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: Group A: MNK6106 2 grams (tid)
Participants receive 2 tablets of MNK6106 three times daily (tid) for 5 days
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1 gram tablet of MNK6106 for oral administration
Other Names:
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Experimental: Group B: MNK6106 4 grams (bid)
Participants receive 4 tablets of MNK6106 twice daily (bid) for 5 days
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1 gram tablet of MNK6106 for oral administration
Other Names:
|
Experimental: Group C: MNK6106 4 grams (tid)
Participants receive 4 tablets of MNK6106 tid for 5 days
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1 gram tablet of MNK6106 for oral administration
Other Names:
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Active Comparator: Group D: Rifaximin 550 mg (bid)
Participants receive 1 tablet of rifaximin bid for 5 days
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550 mg tablet of rifaximin for oral administration
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ammonia Plasma Levels at Baseline and Day 5
Time Frame: Baseline, Day 5
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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. |
Baseline, Day 5
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events by the End of the Trial
Time Frame: within 15 days
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End of trial is defined as 7 (+/-3) days after last study treatment
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within 15 days
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Liver Failure
- Hepatic Insufficiency
- Pathologic Processes
- Metabolic Diseases
- Central Nervous System Diseases
- Nervous System Diseases
- Liver Diseases
- Brain Diseases, Metabolic
- Fibrosis
- Liver Cirrhosis
- Hepatic Encephalopathy
- Brain Diseases
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Gastrointestinal Agents
- Anti-Bacterial Agents
- Rifaximin
- Phenylacetic acid
Other Study ID Numbers
- MNK61062107
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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