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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