Clinical trial NCT01846663: Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy, Safety, And Pharmacokinetics Of Rifaximin 550 Mg In Subjects With Severe Hepatic Impairment And Overt Hepatic Encephalopathy
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Hepatic Encephalopathy
Keywords: Hepatic Encephalopathy
Liver Failure
Hepatic Insufficiency
Liver Diseases
Brain Diseases
Rifaximin
Cirrhosis
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2013-05-03
Enrollment: 6
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 the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.


Eligibility criteria: Inclusion Criteria:

* Male or non-pregnant, non-breast feeding female ≥ 18 years old
* In remission from demonstrated overt HE
* Had ≥1 episode of overt HE associated with liver disease within the last 6 months
* MELD score of ≥ 19
* Has a close family member or other personal contact who is familiar with the subject's HE, can provide continuing oversight to the subject and is willing to be available to the subject during the conduct of the trial

Exclusion Criteria:

* HIV
* History of tuberculosis infection
* Chronic respiratory insufficiency
* Current infection and receiving antibiotics
* Renal insufficiency requiring dialysis
* Active spontaneous bacterial peritonitis infection
* Intestinal obstruction or has inflammatory bowel disease
* Active malignancy within the last 5 years
* Current GI bleeding or has had a GI hemorrhage within past 3 months
* Anemia

Primary outcomes:
measure: Proportion of Participants With Hepatic Encephalopathy (HE) Breakthrough Episode
timeFrame: 6 Months
Secondary outcomes:
measure: Proportion of Participants With HE-related Hospitalization
timeFrame: 6 Months
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: The University of Alabama at Birmingham
state: Alabama
city: Phoenix
country: United States
facility: Banner Research
state: Arizona
city: Tucson
country: United States
facility: University Of Arizona Liver Research Institute
state: Arizona
city: Coronado
country: United States
facility: Southern California Liver Centers
state: California
city: La Jolla
country: United States
facility: UCSD Clinical & Translational Research Institute
state: California
city: Loma Linda
country: United States
facility: Loma Linda University Medical Center Transplantation Institute
state: California
city: Los Angeles
country: United States
facility: University of Southern Califorina Keck School Of Medicine
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: Rialto
country: United States
facility: Inland Empire Liver Foundation
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: New Haven
country: United States
facility: Salix Site
state: Connecticut
city: Tampa
country: United States
facility: Salix Site
state: Florida
city: Atlanta
country: United States
facility: Piedmont Atlanta Hospital
state: Georgia
city: Chicago
country: United States
facility: Northwestern University-Comprehensive Transplant Center
state: Illinois
city: Chicago
country: United States
facility: Rush University Medical Center
state: Illinois
city: New Orleans
country: United States
facility: Tulane Abdominal Transplant Research Office
state: Louisiana
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: New York
country: United States
facility: New York University School of Medicine
state: New York
city: Portland
country: United States
facility: Salix Site
state: Oregon
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Dallas
country: United States
facility: The Liver Institute at Methodist Dallas Medical Center
state: Texas
city: Fort Sam Houston
country: United States
facility: Brook Army Medical Center
state: Texas
city: Galveston
country: United States
facility: Salix Site
state: Texas
city: Houston
country: United States
facility: The Methodist Hospital
state: Texas
city: Richmond
country: United States
facility: McGuire VA Medical Center
state: Virginia
city: Richmond
country: United States
facility: VCU/MCV Health Systems
state: Virginia
city: Seattle
country: United States
facility: Swedish Medical Center
state: Washington
Study officials:
affiliation: Bausch Health Americas, Inc.
name: Varsha Bhatt, Ph.D.
role: STUDY_DIRECTOR
References: