Back to resultsMNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
Primary Purpose
Hepatic Cirrhosis, Hepatic Encephalopathy (HE)
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MNK6106
Rifaximin
Sponsored by
About this trial
This is an interventional treatment trial for Hepatic Cirrhosis
Eligibility Criteria
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
Sites / Locations
- Southern California Research Center
- Inland Empire Clinical Trials
- Global Clinical Professionals
- American Research Corporation at the Texas Liver Institute
- Fundacion de Investigacion (Research Foundation)
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Active Comparator
Arm Label
Group A: MNK6106 2 grams (tid)
Group B: MNK6106 4 grams (bid)
Group C: MNK6106 4 grams (tid)
Group D: Rifaximin 550 mg (bid)
Arm Description
Participants receive 2 tablets of MNK6106 three times daily (tid) for 5 days
Participants receive 4 tablets of MNK6106 twice daily (bid) for 5 days
Participants receive 4 tablets of MNK6106 tid for 5 days
Participants receive 1 tablet of rifaximin bid for 5 days
Outcomes
Primary Outcome Measures
Ammonia Plasma Levels at Baseline and 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 Outcome Measures
Number of Participants With Adverse Events by the End of the Trial
End of trial is defined as 7 (+/-3) days after last study treatment
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03712280
Brief Title
MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
December 1, 2018 (Actual)
Primary Completion Date
July 14, 2020 (Actual)
Study Completion Date
July 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mallinckrodt
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Cirrhosis, Hepatic Encephalopathy (HE)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A: MNK6106 2 grams (tid)
Arm Type
Experimental
Arm Description
Participants receive 2 tablets of MNK6106 three times daily (tid) for 5 days
Arm Title
Group B: MNK6106 4 grams (bid)
Arm Type
Experimental
Arm Description
Participants receive 4 tablets of MNK6106 twice daily (bid) for 5 days
Arm Title
Group C: MNK6106 4 grams (tid)
Arm Type
Experimental
Arm Description
Participants receive 4 tablets of MNK6106 tid for 5 days
Arm Title
Group D: Rifaximin 550 mg (bid)
Arm Type
Active Comparator
Arm Description
Participants receive 1 tablet of rifaximin bid for 5 days
Intervention Type
Drug
Intervention Name(s)
MNK6106
Other Intervention Name(s)
Study Drug, L-Ornithine Phenylacetate
Intervention Description
1 gram tablet of MNK6106 for oral administration
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
Xifaxan
Intervention Description
550 mg tablet of rifaximin for oral administration
Primary Outcome Measure Information:
Title
Ammonia Plasma Levels at Baseline and Day 5
Description
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.
Time Frame
Baseline, Day 5
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events by the End of the Trial
Description
End of trial is defined as 7 (+/-3) days after last study treatment
Time Frame
within 15 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Team Leader
Organizational Affiliation
Mallinckrodt
Official's Role
Study Director
Facility Information:
Facility Name
Southern California Research Center
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Facility Name
Inland Empire Clinical Trials
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Facility Name
Global Clinical Professionals
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33702
Country
United States
Facility Name
American Research Corporation at the Texas Liver Institute
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Fundacion de Investigacion (Research Foundation)
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing 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.
Learn more about this trial
MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
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