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

June 29, 2021 updated by: Mallinckrodt

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

Completed

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • San Juan, Puerto Rico, 00927
        • Fundacion de Investigacion (Research Foundation)
    • California
      • Coronado, California, United States, 92118
        • Southern California Research Center
      • Rialto, California, United States, 92377
        • Inland Empire Clinical Trials
    • Florida
      • Saint Petersburg, Florida, United States, 33702
        • Global Clinical Professionals
    • Texas
      • San Antonio, Texas, United States, 78215
        • American Research Corporation at The Texas Liver Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key 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

Key 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: Group A: MNK6106 2 grams (tid)
Participants receive 2 tablets of MNK6106 three times daily (tid) for 5 days
1 gram tablet of MNK6106 for oral administration
Other Names:
  • Study Drug
  • L-Ornithine Phenylacetate
Experimental: Group B: MNK6106 4 grams (bid)
Participants receive 4 tablets of MNK6106 twice daily (bid) for 5 days
1 gram tablet of MNK6106 for oral administration
Other Names:
  • Study Drug
  • L-Ornithine Phenylacetate
Experimental: Group C: MNK6106 4 grams (tid)
Participants receive 4 tablets of MNK6106 tid for 5 days
1 gram tablet of MNK6106 for oral administration
Other Names:
  • Study Drug
  • L-Ornithine Phenylacetate
Active Comparator: Group D: Rifaximin 550 mg (bid)
Participants receive 1 tablet of rifaximin bid for 5 days
550 mg tablet of rifaximin for oral administration
Other Names:
  • Xifaxan

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

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

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
End of trial is defined as 7 (+/-3) days after last study treatment
within 15 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2018

Primary Completion (Actual)

July 14, 2020

Study Completion (Actual)

July 14, 2020

Study Registration Dates

First Submitted

October 16, 2018

First Submitted That Met QC Criteria

October 17, 2018

First Posted (Actual)

October 19, 2018

Study Record Updates

Last Update Posted (Actual)

July 20, 2021

Last Update Submitted That Met QC Criteria

June 29, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

Discussion of statistical endpoints and analysis are included in manuscripts. Summary aggregate (basic) results (including adverse events information) and the study protocol are made available on clinicaltrials.gov (NCT03712280) when required by regulation. Individual de-identified patient data will not be disclosed. Requests for additional information should be directed to the company at medinfo@mnk.com.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

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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