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

Primary Purpose

Hepatic Encephalopathy

Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Rifaximin
Lactulose
Placebo
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring Encephalopathy, Hepatic, Portosystemic Encephalopathy, Encephalopathy, Hepatocerebral, Encephalopathy, Portal-Systemic, Encephalopathy, Portosystemic, Hepatic Coma, Hepatic Stupor, Hepatocerebral Encephalopathy, Portal-Systemic Encephalopathy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Criteria: 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

Sites / Locations

  • Center For Liver Diseases - University of Miami

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

lactulose given with a placebo (sugar pill)

lactulose given with rifaximin

rifaximin given alone

Arm Description

Outcomes

Primary Outcome Measures

Number of Hospitalizations for Hepatic Encephalopathy (HE)
Changes in Psychometric Testing During Study Period

Secondary Outcome Measures

Number of Hospitalization Days for All Causes
Death or Survival to Liver Transplantation
Rate of Adverse Events With Rifaximin Treatment

Full Information

First Posted
August 15, 2006
Last Updated
August 27, 2019
Sponsor
University of Miami
Collaborators
Bausch Health Americas, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00364689
Brief Title
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

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficult to recruit participants
Study Start Date
August 2006 (Actual)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Miami
Collaborators
Bausch Health Americas, Inc.

4. Oversight

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
Keywords
Encephalopathy, Hepatic, Portosystemic Encephalopathy, Encephalopathy, Hepatocerebral, Encephalopathy, Portal-Systemic, Encephalopathy, Portosystemic, Hepatic Coma, Hepatic Stupor, Hepatocerebral Encephalopathy, Portal-Systemic Encephalopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
lactulose given with a placebo (sugar pill)
Arm Type
Experimental
Arm Title
lactulose given with rifaximin
Arm Type
Experimental
Arm Title
rifaximin given alone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Intervention Type
Drug
Intervention Name(s)
Lactulose
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Number of Hospitalizations for Hepatic Encephalopathy (HE)
Time Frame
Month 7
Title
Changes in Psychometric Testing During Study Period
Time Frame
Month 7
Secondary Outcome Measure Information:
Title
Number of Hospitalization Days for All Causes
Time Frame
Month 7
Title
Death or Survival to Liver Transplantation
Time Frame
Month 7
Title
Rate of Adverse Events With Rifaximin Treatment
Time Frame
Month 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chakradhar Reddy, MD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center For Liver Diseases - University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

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

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