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

Hepatic Cirrhosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03712280
• Other study ID #: MNK61062107
• Status: Completed
• Phase: Phase 2
• Start date: December 1, 2018
• Est. completion date: July 14, 2020

Study information

• Verified date: June 2021
• Source: Mallinckrodt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 14, 2020
• Est. primary completion date: July 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Fibrosis
• Hepatic Cirrhosis
• Hepatic Encephalopathy
• Hepatic Encephalopathy (HE)
• Liver Cirrhosis

Intervention

Drug:
• MNK6106
1 gram tablet of MNK6106 for oral administration
• Rifaximin
550 mg tablet of rifaximin for oral administration

Locations

Country	Name	City	State
Puerto Rico	Fundacion de Investigacion (Research Foundation)	San Juan
United States	Southern California Research Center	Coronado	California
United States	Inland Empire Clinical Trials	Rialto	California
United States	Global Clinical Professionals	Saint Petersburg	Florida
United States	American Research Corporation at the Texas Liver Institute	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Mallinckrodt

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline, Day 5
Secondary	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	within 15 days