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 [Protocol Number: RFHE4044]

Trial ID:
IRB-13-6073
Catherine Frenette
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