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

• Status: Recruiting
• Trial end date: 2022-06-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bausch Health Americas, Inc.; Valeant Pharmaceuticals International, Inc.
• Treatments: Rifamycins; Rifaximin

Criteria

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