Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy



Status:Recruiting
Conditions:Infectious Disease, Neurology, Psychiatric, Gastrointestinal
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases, Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - Any
Updated:4/28/2017
Start Date:April 3, 2013
End Date:June 2021
Contact:Erica Bullock
Email:erica.bullock@salix.com
Phone:919-862-1854

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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

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


Inclusion 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

Exclusion Criteria:

- 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
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Saint Louis, Missouri 63110
Principal Investigator: Jackie Fleckenstein, MD
Phone: 314-362-3839
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Brendan McGuire, MD
Phone: 205-934-1224
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8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Principal Investigator: Vinay Sundaram, MD
Phone: 310-423-5453
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
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1211 Medical Center Dr
Nashville, Tennessee 37232
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Atlanta, Georgia 30309
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
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Phone: 303-724-6559
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Chicago, Illinois 60611
Principal Investigator: Josh Levitsky, MD
Phone: 312-926-0658
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Nikunj Shah, MD
Phone: 312-563-3919
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Coronado, California 92118
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Phone: 619-522-0330
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Dallas, Texas 75203
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Fort Sam Houston, Texas 78234
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Galveston, Texas 77555
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La Jolla, California 92037
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Loma Linda, California 92324
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Los Angeles, California 90033
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New Haven, Connecticut 06520
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550 1st Ave
New York, New York 10016
(212) 263-7300
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Phoenix, Arizona 85016
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Portland, Oregon 97239
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Richmond, Virginia 23249
Principal Investigator: Jasmohan Bajaj, MD
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Richmond, Virginia 23298
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Rochester, Minnesota 55905
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5300 Tallman Ave NW
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