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

Stopped early · Phase 3 · Has a placebo group

Conditions studied: Hepatic Encephalopathy

In brief

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

Key facts

Study ID

NCT00364689

Run by

University of Miami

People needed

13

Starts

2006-08-01

Expected to finish

2008-07-01

Last updated by the study team

2019-09-17

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Center For Liver Diseases - University of Miami — Miami, Florida, United States

Full record on ClinicalTrials.gov

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