Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCSD
Dates
study started
estimated completion
Principal Investigator
by Michael Mendler, MD (ucsd)
Headshot of Michael Mendler
Michael Mendler

Description

Summary

The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.

Official Title

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy, Safety, And Pharmacokinetics Of Rifaximin 550 Mg In Subjects With Severe Hepatic Impairment And Overt Hepatic Encephalopathy

Keywords

Hepatic Encephalopathy Liver Failure Hepatic Insufficiency Liver Diseases Brain Diseases Rifaximin Cirrhosis

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male or non-pregnant, non-breast feeding female ≥ 18 years old
  • In remission from demonstrated overt HE
  • Had ≥1 episode of overt HE associated with liver disease within the last 6 months
  • MELD score of ≥ 19
  • Has a close family member or other personal contact who is familiar with the subject's HE, can provide continuing oversight to the subject and is willing to be available to the subject during the conduct of the trial

You CAN'T join if...

Locations

  • UCSD Clinical & Translational Research Institute accepting new patients
    La Jolla California 92037 United States
  • Cedars-Sinai Medical Center accepting new patients
    Los Angeles California 90048 United States
  • University of Southern Califorina Keck School Of Medicine accepting new patients
    Los Angeles California 90033 United States
  • Southern California Liver Centers accepting new patients
    Coronado California 92118 United States

Lead Scientist at University of California Health

  • Michael Mendler, MD (ucsd)
    Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 43 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bausch Health Americas, Inc.
ID
NCT01846663
Phase
Phase 4 Hepatic Encephalopathy Research Study
Study Type
Interventional
Participants
Expecting 100 study participants
Last Updated