RICE Trial: Rifaximin In Chronic Hepatic Encephalopathy - A Randomized, Controlled Trial

University of Miami

Status and phase: Terminated; Phase 3

Conditions: Hepatic Encephalopathy

Treatments: Drug: Rifaximin; Other: Placebo; Drug: Lactulose

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00364689

20060298 (Other Identifier)

20060006

Details and patient eligibility

About

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

Enrollment: 13 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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13 participants in 3 patient groups

lactulose given with a placebo (sugar pill)

Experimental group

Treatment:

Drug: Lactulose

Other: Placebo

lactulose given with rifaximin

Experimental group

Treatment:

Drug: Rifaximin

Drug: Lactulose

rifaximin given alone

Active Comparator group

Treatment:

Drug: Rifaximin