Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy
- Registration Number
- NCT01846663
- Lead Sponsor
- Bausch Health Americas, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 6
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Placebo, oral, 0 mg BID, 6 months of treatment Rifaximin Rifaximin Rifaximin, oral, 550 mg BID, 6 months of treatment
- Primary Outcome Measures
Name Time Method Proportion of Participants With Hepatic Encephalopathy (HE) Breakthrough Episode 6 Months
- Secondary Outcome Measures
Name Time Method Proportion of Participants With HE-related Hospitalization 6 Months
Trial Locations
- Locations (25)
Loma Linda University Medical Center Transplantation Institute
🇺🇸Loma Linda, California, United States
University of Southern Califorina Keck School Of Medicine
🇺🇸Los Angeles, California, United States
Cedars-Sinai Medical Center
🇺🇸Los Angeles, California, United States
Salix Site
🇺🇸Galveston, Texas, United States
Northwestern University-Comprehensive Transplant Center
🇺🇸Chicago, Illinois, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
Swedish Medical Center
🇺🇸Seattle, Washington, United States
The Liver Institute at Methodist Dallas Medical Center
🇺🇸Dallas, Texas, United States
The Methodist Hospital
🇺🇸Houston, Texas, United States
University Of Arizona Liver Research Institute
🇺🇸Tucson, Arizona, United States
Tulane Abdominal Transplant Research Office
🇺🇸New Orleans, Louisiana, United States
Banner Research
🇺🇸Phoenix, Arizona, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Southern California Liver Centers
🇺🇸Coronado, California, United States
The University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
UCSD Clinical & Translational Research Institute
🇺🇸La Jolla, California, United States
University of Colorado Denver
🇺🇸Aurora, Colorado, United States
Inland Empire Liver Foundation
🇺🇸Rialto, California, United States
Piedmont Atlanta Hospital
🇺🇸Atlanta, Georgia, United States
Washington University
🇺🇸Saint Louis, Missouri, United States
New York University School of Medicine
🇺🇸New York, New York, United States
Brook Army Medical Center
🇺🇸Fort Sam Houston, Texas, United States
McGuire VA Medical Center
🇺🇸Richmond, Virginia, United States
VCU/MCV Health Systems
🇺🇸Richmond, Virginia, United States