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

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

ArmDescriptionAssigned Intervention
Experimental
Rifaximin
Rifaximin, oral, 550 mg BID, 6 months of treatment
  • Drug: Rifaximin
    Rifaximin, oral, 550 mg BID, 6 months treatment
    Other names:
    • XIFAXAN® Tablets
Placebo Comparator
Placebo
Placebo, oral, 0 mg BID, 6 months of treatment
  • Drug: Placebo
    Placebo, oral, 0 mg BID, 6 months of treatment

Recruiting Locations

Tulane Abdominal Transplant Research Office
New Orleans, Louisiana 70112
Contact:
Joni Murray
504-988-6902

More Details

Status
Recruiting
Sponsor
Bausch Health Americas, Inc.

Study Contact

Erica Bullock
919-862-1854
erica.bullock@salix.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.