Status:
TERMINATED
Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy
Lead Sponsor:
Bausch Health Americas, Inc.
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 3 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 22 2016
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT01846663
Start Date
April 3 2013
End Date
February 22 2016
Last Update
January 9 2024
Active Locations (28)
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1
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0111
2
Banner Research
Phoenix, Arizona, United States, 85016
3
University Of Arizona Liver Research Institute
Tucson, Arizona, United States, 85724
4
Southern California Liver Centers
Coronado, California, United States, 92118