search
Back to results

Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy

Primary Purpose

Hepatic Encephalopathy

Status
Recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Placebo
Rifaximin
Sponsored by
Bausch Health Americas, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatic Encephalopathy focused on measuring Hepatic Encephalopathy, Liver Failure, Hepatic Insufficiency, Liver Diseases, Brain Diseases, Rifaximin, Cirrhosis

Eligibility Criteria

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

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

Sites / Locations

  • The University of Alabama at BirminghamRecruiting
  • Banner ResearchRecruiting
  • University Of Arizona Liver Research InstituteRecruiting
  • Southern California Liver CentersRecruiting
  • UCSD Clinical & Translational Research InstituteRecruiting
  • Loma Linda University Medical Center Transplantation InstituteRecruiting
  • University of Southern Califorina Keck School Of MedicineRecruiting
  • Cedars-Sinai Medical CenterRecruiting
  • Inland Empire Liver FoundationRecruiting
  • University of Colorado DenverRecruiting
  • Salix Site
  • Salix Site
  • Piedmont Atlanta HospitalRecruiting
  • Northwestern University-Comprehensive Transplant CenterRecruiting
  • Rush University Medical CenterRecruiting
  • Tulane Abdominal Transplant Research OfficeRecruiting
  • Mayo Clinic
  • Washington UniversityRecruiting
  • New York University School of MedicineRecruiting
  • Salix Site
  • Vanderbilt University Medical CenterRecruiting
  • The Liver Institute at Methodist Dallas Medical CenterRecruiting
  • Brook Army Medical Center
  • Salix Site
  • The Methodist HospitalRecruiting
  • McGuire VA Medical CenterRecruiting
  • VCU/MCV Health SystemsRecruiting
  • Swedish Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rifaximin

Placebo

Arm Description

Rifaximin, oral, 550 mg BID, 6 months of treatment

Placebo, oral, 0 mg BID, 6 months of treatment

Outcomes

Primary Outcome Measures

Time to first Hepatic Encephalopathy(HE) breakthrough episode

Secondary Outcome Measures

Time to first HE-related hospitalization
All Cause Mortality

Full Information

First Posted
April 24, 2013
Last Updated
September 7, 2022
Sponsor
Bausch Health Americas, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT01846663
Brief Title
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

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2013 (Actual)
Primary Completion Date
May 2025 (Anticipated)
Study Completion Date
May 2025 (Anticipated)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Encephalopathy
Keywords
Hepatic Encephalopathy, Liver Failure, Hepatic Insufficiency, Liver Diseases, Brain Diseases, Rifaximin, Cirrhosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Rifaximin
Arm Type
Experimental
Arm Description
Rifaximin, oral, 550 mg BID, 6 months of treatment
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo, oral, 0 mg BID, 6 months of treatment
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo, oral, 0 mg BID, 6 months of treatment
Intervention Type
Drug
Intervention Name(s)
Rifaximin
Other Intervention Name(s)
XIFAXAN® Tablets
Intervention Description
Rifaximin, oral, 550 mg BID, 6 months treatment
Primary Outcome Measure Information:
Title
Time to first Hepatic Encephalopathy(HE) breakthrough episode
Time Frame
6 Months
Secondary Outcome Measure Information:
Title
Time to first HE-related hospitalization
Time Frame
6 Months
Title
All Cause Mortality
Time Frame
6 Months
Other Pre-specified Outcome Measures:
Title
Adverse Events
Time Frame
6 Months
Title
Assessment of Quality of Life
Time Frame
6 Months
Title
Laboratory Parameters (changes in hematology, blood chemistry and urinalysis test results)
Time Frame
6 Months
Title
Vital Signs (changes in blood pressure and heart rate)
Time Frame
6 Months
Title
Electrocardiograms (12 lead ECG findings)
Time Frame
6 months
Title
Neurologic Function (Critical Flicker Frequency (CFF) Test)
Description
The CFF is the frequency at which the subject observes a constant light transition to a flickering light and will be measured in Hertz (Hz).
Time Frame
6 Months
Title
Pharmacokinetics
Description
The pharmacokinetics outcome measures are peak and trough plasma concentrations of rifaximin and rifaximin metabolite at Visit 3 (Day 28) and Visit 8 (Day 168); and additional determinations of rifaximin and rifaximin metabolite plasma concentrations at Visits 4 (Day 56), 5 (Day 84), 6 (Day 120), and 7 (Day 140) for all subjects.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tendai Merriweather
Phone
9085412720
Email
tendai.merriweather@bauschhealth.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Varsha Bhatt, Ph.D.
Organizational Affiliation
Bausch Health Americas, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
The University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Megan Pickering
Phone
205-934-1224
First Name & Middle Initial & Last Name & Degree
Brendan McGuire, MD
Facility Name
Banner Research
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kelly Enders
Phone
602-839-6211
First Name & Middle Initial & Last Name & Degree
Ester Little, MD
Facility Name
University Of Arizona Liver Research Institute
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julie Johnson
Phone
520-626-1208
First Name & Middle Initial & Last Name & Degree
Shahid Habib, MD
Facility Name
Southern California Liver Centers
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monson Petrea
Phone
619-522-0330
Ext
222
First Name & Middle Initial & Last Name & Degree
Tarek Hassanein, MD
Facility Name
UCSD Clinical & Translational Research Institute
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Quigley
Phone
858-657-5147
First Name & Middle Initial & Last Name & Degree
Michael Mendler, MD
Facility Name
Loma Linda University Medical Center Transplantation Institute
City
Loma Linda
State/Province
California
ZIP/Postal Code
92324
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diane Scavone
Phone
909-558-3636
Ext
33634
First Name & Middle Initial & Last Name & Degree
Thomas Amankonah, MD
Facility Name
University of Southern Califorina Keck School Of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Pui Yan
Phone
323-442-8152
First Name & Middle Initial & Last Name & Degree
Linda Sher, MD
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jennifer Luckett
Phone
310-423-5453
First Name & Middle Initial & Last Name & Degree
Vinay Sundaram, MD
Facility Name
Inland Empire Liver Foundation
City
Rialto
State/Province
California
ZIP/Postal Code
92377
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tina Mercado
Phone
909-883-2999
Email
TMercado@IELiverFoundation.com
First Name & Middle Initial & Last Name & Degree
Isma Hafeez
Phone
909-883-2999
Email
ihafeez@ieliverfoundation.com
First Name & Middle Initial & Last Name & Degree
Zeid Kayali, MD
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Haley Isberg
Phone
303-724-6559
First Name & Middle Initial & Last Name & Degree
Lisa Forman, MD
Facility Name
Salix Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520
Country
United States
Individual Site Status
Terminated
Facility Name
Salix Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Piedmont Atlanta Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Becky Slawik
Phone
404-605-3212
First Name & Middle Initial & Last Name & Degree
Lance Stein, MD
Facility Name
Northwestern University-Comprehensive Transplant Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Grace Rivera
Phone
312-926-0658
First Name & Middle Initial & Last Name & Degree
Josh Levitsky, MD
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Diana Giczewski
Phone
312-563-3919
First Name & Middle Initial & Last Name & Degree
Nikunj Shah, MD
Facility Name
Tulane Abdominal Transplant Research Office
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joni Murray
Phone
504-988-6902
First Name & Middle Initial & Last Name & Degree
Luis Balart, MD
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Completed
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Debra Kemp
Phone
314-362-3839
First Name & Middle Initial & Last Name & Degree
Jackie Fleckenstein, MD
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle Sommervil
Phone
212-263-8391
First Name & Middle Initial & Last Name & Degree
Lewis Teperman, MD
Facility Name
Salix Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-1610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tonya Givens
Phone
615-936-1745
First Name & Middle Initial & Last Name & Degree
Michael Porayko, MD
Facility Name
The Liver Institute at Methodist Dallas Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75203
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zena Cooper
Phone
214-947-4463
First Name & Middle Initial & Last Name & Degree
Parvez Mantry, MD
Facility Name
Brook Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Individual Site Status
Completed
Facility Name
Salix Site
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555
Country
United States
Individual Site Status
Terminated
Facility Name
The Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susan Dorman
Phone
713-441-6316
First Name & Middle Initial & Last Name & Degree
Howard Monsour, Jr., MD
Facility Name
McGuire VA Medical Center
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edith Gavis, RN
Phone
804-675-5584
Email
edith.gavis@va.gov
First Name & Middle Initial & Last Name & Degree
Jasmohan Bajaj, MD
Facility Name
VCU/MCV Health Systems
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stephanie Taylor, RN
Phone
804-828-9311
First Name & Middle Initial & Last Name & Degree
Arun Sanyal, MD
Facility Name
Swedish Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy

We'll reach out to this number within 24 hrs