Rifamycin in Minimal Hepatic Encephalopathy (NCT04082780) | Clinical Trial Compass
CompletedPhase 2
Rifamycin in Minimal Hepatic Encephalopathy
United States30 participantsStarted 2019-09-01
Plain-language summary
This is a randomized double-blind placebo-controlled trial of MHE in patients with cirrhosis using rifamycin SV-MMX 600mg BID vs placebo for 30 days with PK, safety, microbiota, brain function and brain MRI endpoints.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age 18-75 years
. Cirrhosis defined by any one of the following
. Cirrhosis on liver biopsy or transient elastography
. Nodular liver on imaging
. Endoscopic or radiological evidence of varices in a patient with chronic liver disease
. Platelet count \<150,000/mm3 and AST/ALT ratio \>1 in a patient with chronic liver disease
. Women of childbearing age will need to be on accepted birth control for 10 days prior to entering study and 30 days after the end of the last dose of the study drug.
. Cognitive impairment on PHES aggregate score \[more than or greater than\] -4SD or EncephalApp Stroop - based on norms published in Allampati et al located at the website www.encephalapp.com17 (This is the accepted diagnosis of minimal HE.)
Exclusion criteria
. Unclear diagnosis of cirrhosis (does not meet the criteria outlined above)
. Child score \>8
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Cirrhosis Dysbiosis Ratio of stool microbiota
Timeframe: 30 days
Trial details
NCT IDNCT04082780
SponsorHunter Holmes Mcguire Veteran Affairs Medical Center
. Increasing trend of ALT and AST in the 2-12 weeks prior to study inclusion (Baseline values established by at least two samples obtained at least 2 weeks and no more than 8-12 weeks apart) to account for disease related changes in liver enzymes and bilirubin while on study that may otherwise be inappropriately attributed to study drug. \>20% increase in baseline serum AST, ALT, ALP and total bilirubin (TBL) will be considered an exclusion criterion.
. Unable to consent, follow for the study duration
. Normal performance on PHES
. Mini-mental status exam\<2518
. Recent alcohol abuse (within 3 months)
. Recent illicit drug abuse (within 3 months) except marijuana