The Safety/Efficacy Of Rifaximin With/Without Lactulose In Subjects With A History Of Recurrent Hepatic Encephalopathy



Status:Completed
Conditions:Infectious Disease, Neurology, Psychiatric, Gastrointestinal
Therapuetic Areas:Gastroenterology, Immunology / Infectious Diseases, Neurology, Psychiatry / Psychology
Healthy:No
Age Range:18 - 99
Updated:4/28/2017
Start Date:January 2013
End Date:June 2014

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A Multicenter, Randomized, Open-Label, Active-Controlled, Trial To Evaluate The Safety And Efficacy Of Rifaximin 550 Mg With And Without Lactulose In Subjects With A History Of Recurrent Overt Hepatic Encephalopathy

The purpose of the study is to evaluate if Rifaximin alone or Rifaximin plus Lactulose
delays the onset of hepatic encephalopathy (HE) in cirrhotic subjects who have had a
previous episode of HE.


Inclusion Criteria:

- Male and non-pregnant, non-lactating females >/= 18 years

- In remission from demonstrated overt HE

- Have had one or more episodes of overt HE associated with cirrhosis in the last 6
months

- Subject has a close family member or other personal contact who is familiar with the
subject's HE and can provide continuing oversight to the subject and is willing to
perform as caregiver 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 inflammatory bowel disease

- Active malignancy within the last 5 years

- Current GI bleeding or has a history of a GI hemorrhage (within last 3 months

- Anemia

- Scheduled to receive a liver transplant within 1 month
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Baltimore, Maryland 21202
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425 University Blvd.
Indianapolis, Indiana 46202
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Asheville, North Carolina 28801
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13001 E. 17th Pl
Aurora, Colorado 80045
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Boston, MA
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Charlotte, North Carolina 28203
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Chicago, Illinois 60611
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Coronado, California 92118
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Des Moines, Iowa 50309
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Englewood, Colorado 80113
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Fresno, California 93721
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Gainesville, Florida 32610
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Houston, Texas 77030
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Jefferson, Louisiana 70124
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425 Volker Boulevard
Kansas City, Missouri 64131
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Long Beach, California 90822
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Macon, Georgia 31201
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600 Highland Ave
Madison, Wisconsin 53792
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Monroe, Louisiana 71201
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New York, New York 10032
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New York, New York 10021
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Odessa, Texas 79761
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Oklahoma City, Oklahoma 73112
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Emile St
Omaha, Nebraska 68198
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Philadelphia, Pennsylvania 19141
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