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Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy

Recruiting
I'm interested

18 years and over
This study is NOT accepting healthy volunteers
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

Drug: Placebo, Drug: Rifaximin

Hepatic Encephalopathy

Hepatic Encephalopathy, Liver Failure, Hepatic Insufficiency, Liver Diseases, Brain Diseases, Rifaximin, Cirrhosis

Tendai Merriweather - tendai.merriweather@bauschhealth.com
Phase 4
NCT01846663
See this study on ClinicalTrials.gov

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