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
Description
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.
Phase
Phase 4 - refines the treatment to become part of standard care.Inclusion and Exclusion Criteria
- 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
Sites
-
California
- University of Southern Califorina Keck School Of Medicine, Los Angeles, California, 90033
- Cedars-Sinai Medical Center, Los Angeles, California, 90048
- Inland Empire Liver Foundation, Rialto, California, 92377
- Loma Linda University Medical Center Transplantation Institute, Loma Linda, California, 92324
- UCSD Clinical & Translational Research Institute, Lajolla, California, 92037
- Southern California Liver Centers, Coronado, California, 92118
-
Arizona
- Banner Research, Phoenix, Arizona, 85016
- University Of Arizona Liver Research Institute, Tuscon, Arizona, 85724
-
Oregon
- Salix Site, Portland, Oregon, 97239
-
Colorado
- University of Colorado Denver, Aurora, Colorado, 80045
-
Washington
- Swedish Medical Center, Seattle, Washington, 98122
-
Texas
- Brook Army Medical Center, Fort Sam Houston, Texas, 78234
- The Liver Institute at Methodist Dallas Medical Center, Dallas, Texas, 75203
- The Methodist Hospital, Houston, Texas, 77030
- Salix Site, Galveston, Texas, 77555
-
Minnesota
- Mayo Clinic, Rochester, Minnesota, 55905
-
Missouri
- Washington University, St. Louis, Missouri, 63110
-
Louisiana
- Tulane Abdominal Transplant Research Office, New Orleans, Louisiana, 70112
-
Illinois
- Rush University Medical Center, Chicago, Illinois, 60612
- Northwestern University-Comprehensive Transplant Center, Chicago, Illinois, 60611
-
Georgia
- Piedmont Atlanta Hospital, Atlanta, Georgia, 30309
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