Status:
TERMINATED
RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial
Lead Sponsor:
University of Miami
Collaborating Sponsors:
Bausch Health Americas, Inc.
Conditions:
Hepatic Encephalopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to compare the effectiveness of three different treatments for hepatic encephalopathy.
Eligibility Criteria
Inclusion
- Cirrhosis of any cause
- History of previous admission for acute HE within 12 months of screening and Conn grade 0-1 HE at time of enrollment
- An Institutional Review Board (IRB/EC) approved informed consent is signed and dated prior to any study-related activities being initiated.
- Subject is a male or a non-pregnant and non-lactating female. Women of non-childbearing potential or who are practicing adequate birth control are eligible. The investigator is responsible for determining whether the subject has adequate birth control for study participation.
- Subject is ≥18 years of age.
- Subject is capable and willing to comply with all study procedures.
- If the subject has a history of a portal-systemic shunt, shunt placement or revision must be \>6 months from Screening for TIPS or a surgical shunt.
Exclusion
- Subject has a significant medical or psychiatric condition which, in the opinion of the Investigator, precludes participation in the study.
- Subject has a history of allergy or intolerance to lactulose.
- Subject has a history of allergy or intolerance to rifampin or rifaximin.
- Subject has participated in an investigational drug or device study within the 30 days prior to study screening.
- Subject is pregnant or is lactating.
- Subject shows evidence of ongoing alcohol or drug dependence, in the opinion of the Investigator.
- Subject has a visual impairment disorder (e.g., glaucoma, diabetic retinopathy, or macular degeneration) or a neurological disease beyond HE that, in the opinion of the Investigator, could impact their performance on neuropsychological assessments and psychometric tests.
- Subject has any condition or circumstance that would, in the opinion of the Investigator, prevent completion of the study or interfere with analysis of study results, including history of noncompliance with treatments or visits.
- Subject's current, required medications are on prohibited concurrent medication listing.
- Hemoglobin \< 8.0 at time of screening
- Severe hypovolemia or electrolyte abnormalities that would be likely to affect mental function (serum sodium less than 120 mEq/L, serum calcium greater than 11 mg/dL) at time of screening
- Ongoing gastrointestinal bleeding at time of screening
- Chronic renal insufficiency with a serum creatinine \> 3.0 at time of screening
- History of tuberculosis infection
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00364689
Start Date
August 1 2006
End Date
July 1 2008
Last Update
September 17 2019
Active Locations (1)
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1
Center For Liver Diseases - University of Miami
Miami, Florida, United States, 33136