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 |
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.
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
We found this trial at
43
sites
New York, New York 10032
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Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
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University of Colorado Denver The University of Colorado Denver | Anschutz Medical Campus provides a...
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Chapel Hill, North Carolina 27599
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600 Highland Ave
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
University of Wisconsin Hospital and Clinics UW Health strives to meet the health needs of...
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Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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