Summary

for people ages 18 years and up (full criteria)
at La Jolla, California and other locations
study started
estimated completion:

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 Rifamycins

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...

  • HIV
  • History of tuberculosis infection
  • Chronic respiratory insufficiency
  • Current infection and receiving antibiotics
  • Renal insufficiency requiring dialysis
  • Active spontaneous bacterial peritonitis infection
  • Intestinal obstruction or has inflammatory bowel disease
  • Active malignancy within the last 5 years
  • Current GI bleeding or has had a GI hemorrhage within past 3 months
  • Anemia

Locations

  • UCSD Clinical & Translational Research Institute accepting new patients
    La Jolla California 92037 United States
  • Southern California Liver Centers accepting new patients
    Coronado California 92118 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Valeant Pharmaceuticals International, Inc.
ID
NCT01846663
Phase
Phase 4
Study Type
Interventional
Last Updated