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 range18 Years ā 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
ā. Age 18-75 years
ā. Cirrhosis defined by any one of the following
ā. Cirrhosis on liver biopsy or transient elastography
ā. Nodular liver on imaging
ā. Endoscopic or radiological evidence of varices in a patient with chronic liver disease
ā. Platelet count \<150,000/mm3 and AST/ALT ratio \>1 in a patient with chronic liver disease
ā. 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.
ā. 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
ā. Unclear diagnosis of cirrhosis (does not meet the criteria outlined above)
ā. Child score \>8
ā. 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.
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