At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 50 enrolled
Drug / intervention
MNK6106 +1 moredrug
Likely dose
Rifaximin 550 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating MNK6106 and Rifaximin for Hepatic Cirrhosis and Hepatic Encephalopathy (HE). Completed, enrolled 50 participants across 5 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatic Cirrhosis, Hepatic Encephalopathy (HE)
CountriesPuerto Rico, United States
Collaborators--
Timeline
Phase 2CompletedFinished
20192020202120222023202420252026
First PostedOct 2018
Enrollment StartDec 2018
Primary CompletionJul 2020
TodayJul 2026
First PostedOct 19, 2018
Enrollment StartDec 1, 2018
Primary CompletionJul 14, 2020
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 7.7 years ago
Interventions
MNK6106drug
1 gram tablet of MNK6106 for oral administration
Rifaximindrug
550 mg tablet of rifaximin for oral administration