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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Salix Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01846663
First received: April 24, 2013
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.


Condition Intervention Phase
Hepatic Encephalopathy
Drug: Placebo
Drug: Rifaximin
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:
  • Time to first Hepatic Encephalopathy(HE) breakthrough episode [ Time Frame: 6 Months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to first HE-related hospitalization [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • All Cause Mortality [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Adverse Events [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Assessment of Quality of Life [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
  • Laboratory Parameters (changes in hematology, blood chemistry and urinalysis test results) [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Vital Signs (changes in blood pressure and heart rate) [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
  • Electrocardiograms (12 lead ECG findings) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
  • Neurologic Function (Critical Flicker Frequency (CFF) Test) [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
    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).

  • Pharmacokinetics [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 100
Study Start Date: April 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Rifaximin
Rifaximin, oral, 550 mg BID, 6 months of treatment
Drug: Rifaximin
Rifaximin, oral, 550 mg BID, 6 months treatment
Other Name: XIFAXAN® Tablets
Placebo Comparator: Placebo
Placebo, oral, 0 mg BID, 6 months of treatment
Drug: Placebo
Placebo, oral, 0 mg BID, 6 months of treatment

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01846663

Contacts
Contact: Erica Bullock 919-862-1854 erica.bullock@salix.com

  Hide Study Locations
Locations
United States, Alabama
The University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294-0111
Contact: Megan Pickering    205-934-1224      
Principal Investigator: Brendan McGuire, MD         
United States, Arizona
Banner Research Recruiting
Phoenix, Arizona, United States, 85016
Contact: Kelly Enders    602-839-6211      
Principal Investigator: Ester Little, MD         
University Of Arizona Liver Research Institute Recruiting
Tuscon, Arizona, United States, 85724
Contact: Julie Johnson    520-626-1208      
Principal Investigator: Shahid Habib, MD         
United States, California
Southern California Liver Centers Recruiting
Coronado, California, United States, 92118
Contact: Monson Petrea    619-522-0330 ext 222      
Principal Investigator: Tarek Hassanein, MD         
UCSD Clinical & Translational Research Institute Recruiting
Lajolla, California, United States, 92037
Contact: Sharon Quigley    858-657-5147      
Principal Investigator: Michael Mendler, MD         
Loma Linda University Medical Center Transplantation Institute Recruiting
Loma Linda, California, United States, 92324
Contact: Diane Scavone    909-558-3636 ext 33634      
Principal Investigator: Thomas Amankonah, MD         
Cedars-Sinai Medical Center Recruiting
Los Angeles, California, United States, 90048
Contact: Jennifer Luckett    310-423-5453      
Principal Investigator: Vinay Sundaram, MD         
University of Southern Califorina Keck School Of Medicine Recruiting
Los Angeles, California, United States, 90033
Contact: Pui Yan    323-442-8152      
Principal Investigator: Linda Sher, MD         
Inland Empire Liver Foundation Recruiting
Rialto, California, United States, 92377
Contact: Tina Mercado    909-883-2999    TMercado@IELiverFoundation.com   
Contact: Isma Hafeez    909-883-2999    ihafeez@ieliverfoundation.com   
Principal Investigator: Zeid Kayali, MD         
United States, Colorado
University of Colorado Denver Recruiting
Aurora, Colorado, United States, 80045
Contact: Haley Isberg    303-724-6559      
Principal Investigator: Lisa Forman, MD         
United States, Connecticut
Salix Site Terminated
New Haven, Connecticut, United States, 06520
United States, Florida
Salix Site Not yet recruiting
Tampa, Florida, United States, 33606
United States, Georgia
Piedmont Atlanta Hospital Recruiting
Atlanta, Georgia, United States, 30309
Contact: Becky Slawik    404-605-3212      
Principal Investigator: Lance Stein, MD         
United States, Illinois
Northwestern University-Comprehensive Transplant Center Recruiting
Chicago, Illinois, United States, 60611
Contact: Grace Rivera    312-926-0658      
Principal Investigator: Josh Levitsky, MD         
Rush University Medical Center Recruiting
Chicago, Illinois, United States, 60612
Contact: Diana Giczewski    312-563-3919      
Principal Investigator: Nikunj Shah, MD         
United States, Louisiana
Tulane Abdominal Transplant Research Office Recruiting
New Orleans, Louisiana, United States, 70112
Contact: Joni Murray    504-988-6902      
Principal Investigator: Luis Balart, MD         
United States, Minnesota
Mayo Clinic Completed
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University Recruiting
St. Louis, Missouri, United States, 63110
Contact: Debra Kemp    314-362-3839      
Principal Investigator: Jackie Fleckenstein, MD         
United States, New York
New York University School of Medicine Recruiting
New York, New York, United States, 10016
Contact: Christelle Sommervil    212-263-8391      
Principal Investigator: Lewis Teperman, MD         
United States, Oregon
Salix Site Not yet recruiting
Portland, Oregon, United States, 97239
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37212-1610
Contact: Tonya Givens    615-936-1745      
Principal Investigator: Michael Porayko, MD         
United States, Texas
The Liver Institute at Methodist Dallas Medical Center Recruiting
Dallas, Texas, United States, 75203
Contact: Zena Cooper    214-947-4463      
Principal Investigator: Parvez Mantry, MD         
Brook Army Medical Center Completed
Fort Sam Houston, Texas, United States, 78234
Salix Site Terminated
Galveston, Texas, United States, 77555
The Methodist Hospital Recruiting
Houston, Texas, United States, 77030
Contact: Susan Dorman    713-441-6316      
Principal Investigator: Howard Monsour, Jr., MD         
United States, Virginia
McGuire VA Medical Center Recruiting
Richmond, Virginia, United States, 23249
Contact: Edith Gavis, RN    804-675-5584    edith.gavis@va.gov   
Principal Investigator: Jasmohan Bajaj, MD         
VCU/MCV Health Systems Recruiting
Richmond, Virginia, United States, 23298
Contact: Stephanie Taylor, RN    804-828-9311      
Principal Investigator: Arun Sanyal, MD         
United States, Washington
Swedish Medical Center Completed
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Salix Pharmaceuticals
Investigators
Study Director: Enoch Bortey, Ph.D. Salix Pharmaceuticals
  More Information

No publications provided

Responsible Party: Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01846663     History of Changes
Other Study ID Numbers: RFHE4043
Study First Received: April 24, 2013
Last Updated: July 15, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Salix Pharmaceuticals:
Hepatic Encephalopathy
Liver Failure
Hepatic Insufficiency
Liver Diseases
Brain Diseases
Rifaximin
Cirrhosis

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Brain Diseases, Metabolic
Central Nervous System Diseases
Digestive System Diseases
Hepatic Insufficiency
Liver Diseases
Liver Failure
Metabolic Diseases
Nervous System Diseases
Rifaximin
Anti-Infective Agents
Gastrointestinal Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on October 23, 2014