Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy
Purpose
The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.
Condition
- Hepatic Encephalopathy
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Phase 4
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Rifaximin |
Rifaximin, oral, 550 mg BID, 6 months of treatment |
|
|
Placebo Comparator Placebo |
Placebo, oral, 0 mg BID, 6 months of treatment |
|
More Details
- Status
- Terminated
- Sponsor
- Bausch Health Americas, Inc.