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

Hepatic Encephalopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00364689
• Other study ID #: 20060006
• Secondary ID: 20060298
• Status: Terminated
• Phase: Phase 3
• Start date: August 2006
• Est. completion date: July 2008

Study information

• Verified date: August 2019
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: July 2008
• Est. primary completion date: July 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Diseases
• Hepatic Encephalopathy

Intervention

Drug:
• Rifaximin

• Lactulose

Other:
• Placebo

Locations

Country	Name	City	State
United States	Center For Liver Diseases - University of Miami	Miami	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Miami	Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Hospitalizations for Hepatic Encephalopathy (HE)		Month 7
Primary	Changes in Psychometric Testing During Study Period		Month 7
Secondary	Number of Hospitalization Days for All Causes		Month 7
Secondary	Death or Survival to Liver Transplantation		Month 7
Secondary	Rate of Adverse Events With Rifaximin Treatment		Month 7