A Phase 2 interventional study of MNK6106 and Rifaximin in Hepatic Cirrhosis and Hepatic Encephalopathy (HE), sponsored by Mallinckrodt. Completed at 5 sites in 2 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-07-20.
Sponsored by Mallinckrodt · Phase 2, Interventional, and Treatment
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.
1,298 studies on the registry are indexed under Liver Cirrhosis; 338 are open to participants now.
This study's enrollment of 50 is below the median of 78 across 739 interventional studies indexed under Liver Cirrhosis.
Browse Liver Cirrhosis studies →Mallinckrodt is the lead sponsor of 87 studies on the registry; none are open to participants now.
Of its 15 completed or terminated interventional studies of FDA-regulated products, 15 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
A potential participant may only be included if (at screening), he/she:
Key Exclusion Criteria:
A potential participant will be excluded if (at screening), he/she:
Has cancer, infection, lab abnormalities, or any other condition that, per protocol or in the opinion of the investigator might compromise:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive 2 tablets of MNK6106 three times daily (tid) for 5 days
Drug: MNK6106
Participants receive 4 tablets of MNK6106 twice daily (bid) for 5 days
Drug: MNK6106
Participants receive 4 tablets of MNK6106 tid for 5 days
Drug: MNK6106
Participants receive 1 tablet of rifaximin bid for 5 days
Drug: Rifaximin
1 gram tablet of MNK6106 for oral administration
Also known as: Study Drug, L-Ornithine Phenylacetate
550 mg tablet of rifaximin for oral administration
Also known as: Xifaxan
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.
Time frame: Baseline, Day 5
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
Time frame: within 15 days
All 50 participants were enrolled in the United States and Puerto Rico
| Milestone | Group A: MNK6106 2 Grams (Tid) | Group B: MNK6106 4 Grams (Bid) | Group C: MNK6106 4 Grams (Tid) | Group D: Rifaximin 550 mg (Bid) |
|---|---|---|---|---|
| Started | 12 | 12 | 13 | 13 |
| Safety population | 12 | 11 | 13 | 12 |
| Modified intent to treat population | 12 | 11 | 13 | 12 |
| Completed 5 day treatment | 11 | 11 | 12 | 12 |
| Completed | 11 | 11 | 12 | 12 |
| Not completed | 1 | 1 | 1 | 1 |
| Withdrew: Randomized, but not treated due to adverse event | 0 | 1 | 0 | 1 |
| Withdrew: Withdrawal by participant or caregiver | 1 | 0 | 0 | 0 |
| Withdrew: Adverse event | 0 | 0 | 1 | 0 |
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.
| μmol/L | Group A: MNK6106 2 Grams (Tid) | Group B: MNK6106 4 Grams (Bid) | Group C: MNK6106 4 Grams (Tid) | Group D: Rifaximin 550 mg (Bid) |
|---|---|---|---|---|
| Baseline | 70.4 ± 23.4 | 91.4 ± 35.0 | 92.6 ± 34.7 | 78.1 ± 25.0 |
| Day 5/Pre-Dose in the Morning | 72.7 ± 21.8 | 63.9 ± 16.9 | 74.9 ± 21.9 | 75.8 ± 31.3 |
| Day 5/4 Hours Post Morning Dose | 69.8 ± 27.7 | 60.9 ± 13.3 | 73.0 ± 11.5 | 71.6 ± 29.5 |
End of trial is defined as 7 (+/-3) days after last study treatment
| Participants | Group A: MNK6106 2 Grams (Tid) | Group B: MNK6106 4 Grams (Bid) | Group C: MNK6106 4 Grams (Tid) | Group D: Rifaximin 550 mg (Bid) |
|---|---|---|---|---|
| Affected by Serious Adverse Events | 0 | 0 | 2 | 0 |
| Affected by Any Non-serious Adverse Event | 5 | 6 | 9 | 5 |
| Affected by Non-serious Adverse Events in the 5% Reporting Threshold | 5 | 6 | 8 | 5 |
Collected over within 15 days. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A: MNK6106 2 Grams (Tid) | 0/12 (0%) | 0/12 (0%) | 5/12 (41.7%) |
| Group B: MNK6106 4 Grams (Bid) | 0/11 (0%) | 0/11 (0%) | 6/11 (54.5%) |
| Group C: MNK6106 4 Grams (Tid) | 0/13 (0%) | 2/13 (15.4%) | 8/13 (61.5%) |
| Group D: Rifaximin 550 mg (Bid) | 0/12 (0%) | 0/12 (0%) | 5/12 (41.7%) |
| Event | Group A: MNK6106 2 Grams (Tid) | Group B: MNK6106 4 Grams (Bid) | Group C: MNK6106 4 Grams (Tid) | Group D: Rifaximin 550 mg (Bid) |
|---|---|---|---|---|
| AscitesGastrointestinal disorders | 0/12 | 0/11 | 1/13 | 0/12 |
| Haemorrhoidal haemorrhageGastrointestinal disorders | 0/12 | 0/11 | 1/13 | 0/12 |
| HyponatraemiaMetabolism and nutrition disorders | 0/12 | 0/11 | 1/13 | 0/12 |
| Confusional statePsychiatric disorders | 0/12 | 0/11 | 1/13 | 0/12 |
| Event | Group A: MNK6106 2 Grams (Tid) | Group B: MNK6106 4 Grams (Bid) | Group C: MNK6106 4 Grams (Tid) | Group D: Rifaximin 550 mg (Bid) |
|---|---|---|---|---|
| HypotensionVascular disorders | 1/12 | 2/11 | 0/13 | 2/12 |
| VomitingGastrointestinal disorders | 2/12 | 0/11 | 2/13 | 0/12 |
| NauseaGastrointestinal disorders | 1/12 | 0/11 | 2/13 | 0/12 |
| DizzinessNervous system disorders | 0/12 | 0/11 | 2/13 | 1/12 |
| Abdominal pain upperGastrointestinal disorders | 0/12 | 1/11 | 1/13 | 0/12 |
| FatigueGeneral disorders | 0/12 | 1/11 | 1/13 | 0/12 |
| Oedema peripheralGeneral disorders | 0/12 | 1/11 | 0/13 | 0/12 |
| HypokalaemiaMetabolism and nutrition disorders | 0/12 | 1/11 | 0/13 | 1/12 |
| AnaemiaBlood and lymphatic system disorders | 1/12 | 0/11 | 0/13 | 1/12 |
| Vision blurredEye disorders | 1/12 | 0/11 | 0/13 | 0/12 |
All participants randomized
| Age, Categorical(Participants) | Group A: MNK6106 2 Grams (Tid) | Group B: MNK6106 4 Grams (Bid) | Group C: MNK6106 4 Grams (Tid) | Group D: Rifaximin 550 mg (Bid) | Total |
|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 11 | 10 | 10 | 11 | 42 |
| >=65 years | 1 | 1 | 3 | 1 | 6 |
| Age, Continuous(years) | Group A: MNK6106 2 Grams (Tid) | Group B: MNK6106 4 Grams (Bid) | Group C: MNK6106 4 Grams (Tid) | Group D: Rifaximin 550 mg (Bid) | Total |
|---|---|---|---|---|---|
| Mean | 57.2 ± 8.10 | 58.2 ± 7.95 | 58.2 ± 10.56 | 55.2 ± 9.09 | 57.2 ± 8.84 |
| Sex: Female, Male(Participants) | Group A: MNK6106 2 Grams (Tid) | Group B: MNK6106 4 Grams (Bid) | Group C: MNK6106 4 Grams (Tid) | Group D: Rifaximin 550 mg (Bid) | Total |
|---|---|---|---|---|---|
| Female | 6 | 3 | 5 | 6 | 20 |
| Male | 6 | 8 | 8 | 6 | 28 |
| Ethnicity (NIH/OMB)(Participants) | Group A: MNK6106 2 Grams (Tid) | Group B: MNK6106 4 Grams (Bid) | Group C: MNK6106 4 Grams (Tid) | Group D: Rifaximin 550 mg (Bid) | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 11 | 7 | 7 | 10 | 35 |
| Not Hispanic or Latino | 1 | 4 | 6 | 2 | 13 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Group A: MNK6106 2 Grams (Tid) | Group B: MNK6106 4 Grams (Bid) | Group C: MNK6106 4 Grams (Tid) | Group D: Rifaximin 550 mg (Bid) | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 0 | 1 | 3 |
| White | 10 | 11 | 11 | 11 | 43 |
| More than one race | 0 | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 0 | 1 |
| Region of Enrollment(participants) | Group A: MNK6106 2 Grams (Tid) | Group B: MNK6106 4 Grams (Bid) | Group C: MNK6106 4 Grams (Tid) | Group D: Rifaximin 550 mg (Bid) | Total |
|---|---|---|---|---|---|
| United States | 12 | 11 | 13 | 12 | 48 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: 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.
This study is completed, as verified in Jun 2021. You cannot join it, but the record below documents what was studied.
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