Clinical trial NCT00364689: RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial
Official title: RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hepatic Encephalopathy
Keywords: Encephalopathy, Hepatic
Portosystemic Encephalopathy
Encephalopathy, Hepatocerebral
Encephalopathy, Portal-Systemic
Encephalopathy, Portosystemic
Hepatic Coma
Hepatic Stupor
Hepatocerebral Encephalopathy
Portal-Systemic Encephalopathy
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Bausch Health Americas, Inc.
First posted: 2006-08-16
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the effectiveness of three different treatments for hepatic encephalopathy.


Eligibility criteria: Inclusion Criteria:

1. Cirrhosis of any cause
2. History of previous admission for acute HE within 12 months of screening and Conn grade 0-1 HE at time of enrollment
3. An Institutional Review Board (IRB/EC) approved informed consent is signed and dated prior to any study-related activities being initiated.
4. 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.
5. Subject is ≥18 years of age.
6. Subject is capable and willing to comply with all study procedures.
7. 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 Criteria:

1. Subject has a significant medical or psychiatric condition which, in the opinion of the Investigator, precludes participation in the study.
2. Subject has a history of allergy or intolerance to lactulose.
3. Subject has a history of allergy or intolerance to rifampin or rifaximin.
4. Subject has participated in an investigational drug or device study within the 30 days prior to study screening.
5. Subject is pregnant or is lactating.
6. Subject shows evidence of ongoing alcohol or drug dependence, in the opinion of the Investigator.
7. 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.
8. 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.
9. Subject's current, required medications are on prohibited concurrent medication listing.
10. Hemoglobin \< 8.0 at time of screening
11. 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
12. Ongoing gastrointestinal bleeding at time of screening
13. Chronic renal insufficiency with a serum creatinine \> 3.0 at time of screening
14. History of tuberculosis infection

Primary outcomes:
measure: Number of Hospitalizations for Hepatic Encephalopathy (HE)
timeFrame: Month 7
measure: Changes in Psychometric Testing During Study Period
timeFrame: Month 7
Secondary outcomes:
measure: Number of Hospitalization Days for All Causes
timeFrame: Month 7
measure: Death or Survival to Liver Transplantation
timeFrame: Month 7
measure: Rate of Adverse Events With Rifaximin Treatment
timeFrame: Month 7
Other outcomes:
Locations:
city: Miami
country: United States
facility: Center For Liver Diseases - University of Miami
state: Florida
Study officials:
affiliation: University of Miami
name: Chakradhar Reddy, MD
role: PRINCIPAL_INVESTIGATOR
References: