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
We found this trial at
28
sites
Galveston, Texas 77555
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1720 2nd Ave S
Birmingham, Alabama 35233
(205) 934-4011 
Principal Investigator: Brendan McGuire, MD
Phone: 205-934-1224
University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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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
(615) 322-5000
Principal Investigator: Michael Porayko, MD
Phone: 615-936-1745
Vanderbilt Univ Med Ctr Vanderbilt University Medical Center (VUMC) is a comprehensive healthcare facility dedicated...
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Atlanta, Georgia 30309
Principal Investigator: Lance Stein, MD
Phone: 404-605-3212
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Atlanta, GA
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13001 E. 17th Pl
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Lisa Forman, MD
Phone: 303-724-6559
University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Chicago, Illinois 60611
Principal Investigator: Josh Levitsky, MD
Phone: 312-926-0658
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Chicago, IL
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1653 W. Congress Parkway
Chicago, Illinois 60612
(312) 942-5000
Principal Investigator: Nikunj Shah, MD
Phone: 312-563-3919
Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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Coronado, California 92118
Principal Investigator: Tarek Hassanein, MD
Phone: 619-522-0330
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Dallas, Texas 75203
Principal Investigator: Parvez Mantry, MD
Phone: 214-947-4463
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Fort Sam Houston, Texas 78234
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Houston, Texas 77030
Principal Investigator: Howard Monsour, Jr., MD
Phone: 713-441-6316
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Houston, TX
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La Jolla, California 92037
Principal Investigator: Michael Mendler, MD
Phone: 858-657-5147
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Loma Linda, California 92324
Principal Investigator: Thomas Amankonah, MD
Phone: 909-558-3636
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Los Angeles, California 90033
Principal Investigator: Linda Sher, MD
Phone: 323-442-8152
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New Haven, Connecticut 06520
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New Orleans, Louisiana 70112
Principal Investigator: Luis Balart, MD
Phone: 504-988-6902
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550 1st Ave
New York, New York 10016
(212) 263-7300
Principal Investigator: Lewis Teperman, MD
Phone: 212-263-8391
New York University School of Medicine NYU School of Medicine has a proud history that...
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Phoenix, Arizona 85016
Principal Investigator: Ester Little, MD
Phone: 602-839-6211
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Portland, Oregon 97239
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Rialto, California 92377
Principal Investigator: Zeid Kayali, MD
Phone: 909-883-2999
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Richmond, Virginia 23249
Principal Investigator: Jasmohan Bajaj, MD
Phone: 804-675-5584
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Richmond, Virginia 23298
Principal Investigator: Arun Sanyal, MD
Phone: 804-828-9311
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Rochester, Minnesota 55905
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Saint Louis, Missouri 63110
Principal Investigator: Jackie Fleckenstein, MD
Phone: 314-362-3839
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5300 Tallman Ave NW
Seattle, Washington 98122
(206) 782-2700
Swedish Medical Center Since 1910, Swedish has been the region's hallmark for excellence in health...
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Tampa, Florida 33619
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Tucson, Arizona 85724
Principal Investigator: Shahid Habib, MD
Phone: 520-626-1208
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