Hepatic CirrhosisPhase 2NCT03712280
MNK6106 for Liver Disease (Hepatic Cirrhosis) That in the Past Has Affected the Brain (Hepatic Encephalopathy)
A Phase 2 study testing MNK6106 and Rifaximin in people with Hepatic Cirrhosis and Hepatic Encephalopathy (HE), run by Mallinckrodt at 5 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Hepatic Cirrhosis, Hepatic Encephalopathy (HE)
- What is being tested?
- MNK6106 and Rifaximin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 1 Dec 2018to 14 Jul 2020
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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:
Show all 9Show fewer
- the safety and well-being of the participant or potential offspring
- the safety of study staff
- the analysis of results
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
United States4 sites
Southern California Research Center
Coronado, California, 92118
Inland Empire Clinical Trials
Rialto, California, 92377
American Research Corporation at the Texas Liver Institute
San Antonio, Texas, 78215
Global Clinical Professionals
St. Petersburg, Florida, 33702
Puerto Rico1 site
Fundacion de Investigacion (Research Foundation)
San Juan, 00927
About this study
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
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.
- Conditions
- Hepatic Cirrhosis, Hepatic Encephalopathy (HE)
- Being tested
- MNK6106, Rifaximin
- Medical subject headings
- Liver Cirrhosis, Hepatic Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MNK6106Drug
Also called Study Drug, L-Ornithine Phenylacetate
1 gram tablet of MNK6106 for oral administration
RifaximinDrug
Also called Xifaxan
550 mg tablet of rifaximin for oral administration
| Study group | Role | What they receive |
|---|---|---|
| Group A: MNK6106 2 grams (tid) | Experimental | Participants receive 2 tablets of MNK6106 three times daily (tid) for 5 days Receives: Drug: MNK6106 |
| Group B: MNK6106 4 grams (bid) | Experimental | Participants receive 4 tablets of MNK6106 twice daily (bid) for 5 days Receives: Drug: MNK6106 |
| Group C: MNK6106 4 grams (tid) | Experimental | Participants receive 4 tablets of MNK6106 tid for 5 days Receives: Drug: MNK6106 |
| Group D: Rifaximin 550 mg (bid) | Active comparator | Participants receive 1 tablet of rifaximin bid for 5 days Receives: Drug: Rifaximin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 5
Secondary outcomes (1)
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
Measured: within 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2018
- Study start1 Dec 2018
- Primary completion14 Jul 2020
- Study completion14 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatic CirrhosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mallinckrodt
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Team Leader, Study director, Mallinckrodt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03712280
- Sponsor's protocol ID
- MNK61062107
- Status last verified
- Jun 2021
- First submitted
- 16 Oct 2018
- Last updated
- 20 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03712280
- Acronym / sponsor ID
- MNK61062107
- Conditions
- Hepatic Cirrhosis, Hepatic Encephalopathy (HE)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- MallinckrodtIndustry (pharma, biotech, devices)
- Study start
- 1 Dec 2018 (actual)
- Primary completion
- 14 Jul 2020 (actual)
- Study completion
- 14 Jul 2020 (actual)
- First posted
- 19 Oct 2018 (actual)
- Results
- Posted 20 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A: MNK6106 2 grams (tid) | Experimental | Drug: MNK6106Participants receive 2 tablets of MNK6106 three times daily (tid) for 5 days |
| Group B: MNK6106 4 grams (bid) | Experimental | Drug: MNK6106Participants receive 4 tablets of MNK6106 twice daily (bid) for 5 days |
| Group C: MNK6106 4 grams (tid) | Experimental | Drug: MNK6106Participants receive 4 tablets of MNK6106 tid for 5 days |
| Group D: Rifaximin 550 mg (bid) | Active comparator | Drug: RifaximinParticipants receive 1 tablet of rifaximin bid for 5 days |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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 (9 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MNK6106Also: Study Drug, L-Ornithine Phenylacetate1 gram tablet of MNK6106 for oral administration | Drug | Group A: MNK6106 2 grams (tid), Group B: MNK6106 4 grams (bid), Group C: MNK6106 4 grams (tid) |
| RifaximinAlso: Xifaxan550 mg tablet of rifaximin for oral administration | Drug | Group D: Rifaximin 550 mg (bid) |
Primary outcome
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.
1 secondary outcome
Number of Participants With Adverse Events by the End of the Trial
Time frame: within 15 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. 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.
Related trials for Hepatic Cirrhosis
RecruitingObservational study
Effectiveness and Clinical Outcomes of Long-term Bulevirtide Monotherapy in Patients With HDV-related Compensated Cirrhosis
Hepatitis D
Recruiting
Optimal Treatment Strategy for Spontaneous Bacterial Peritonitis
Spontaneous Bacterial Peritonitis, Paracentesis
RecruitingObservational study
The Value of Spleen Thickness and Spleen Diameter for Gastroesophageal Varices Diagnosis in Compensated Cirrhosis
Liver Cirrhosis, Gastroesophageal Varices
Recruiting
CirrhosisRx CDS System
Cirrhosis, Decision Support Systems, Clinical
RecruitingPhase 3
Trial to Evaluate ALN-CIDEB in Adults With Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Metabolic Dysfunction-Associated Steatotic Liver Disease, MASLD
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Team Leader study director
Mallinckrodt
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing MNK6106 and Rifaximin in people with Hepatic Cirrhosis and Hepatic Encephalopathy (HE), run by Mallinckrodt at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ammonia Plasma Levels at Baseline and Day 5 (time frame: Baseline, Day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2021.