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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2014 by Valeant Pharmaceuticals International, Inc..
Recruitment status was:  Recruiting
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
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 Valeant Pharmaceuticals International, Inc.:

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   (Adult, Senior)
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

  Hide Study Locations
Locations
United States, Alabama
The University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-0111
United States, Arizona
Banner Research
Phoenix, Arizona, United States, 85016
University Of Arizona Liver Research Institute
Tuscon, Arizona, United States, 85724
United States, California
Southern California Liver Centers
Coronado, California, United States, 92118
UCSD Clinical & Translational Research Institute
Lajolla, California, United States, 92037
Loma Linda University Medical Center Transplantation Institute
Loma Linda, California, United States, 92324
University of Southern Califorina Keck School Of Medicine
Los Angeles, California, United States, 90033
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Inland Empire Liver Foundation
Rialto, California, United States, 92377
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
United States, Connecticut
Salix Site
New Haven, Connecticut, United States, 06520
United States, Florida
Salix Site
Tampa, Florida, United States, 33606
United States, Georgia
Piedmont Atlanta Hospital
Atlanta, Georgia, United States, 30309
United States, Illinois
Northwestern University-Comprehensive Transplant Center
Chicago, Illinois, United States, 60611
Rush University Medical Center
Chicago, Illinois, United States, 60612
United States, Louisiana
Tulane Abdominal Transplant Research Office
New Orleans, Louisiana, United States, 70112
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University
St. Louis, Missouri, United States, 63110
United States, New York
New York University School of Medicine
New York, New York, United States, 10016
United States, Oregon
Salix Site
Portland, Oregon, United States, 97239
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37212-1610
United States, Texas
The Liver Institute at Methodist Dallas Medical Center
Dallas, Texas, United States, 75203
Brook Army Medical Center
Fort Sam Houston, Texas, United States, 78234
Salix Site
Galveston, Texas, United States, 77555
The Methodist Hospital
Houston, Texas, United States, 77030
United States, Virginia
McGuire VA Medical Center
Richmond, Virginia, United States, 23249
VCU/MCV Health Systems
Richmond, Virginia, United States, 23298
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98122
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Investigators
Study Director: Enoch Bortey, Ph.D. Valeant Pharmaceuticals International, Inc.
  More Information

Responsible Party: Valeant Pharmaceuticals International, Inc.
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 Valeant Pharmaceuticals International, Inc.:
Hepatic Encephalopathy
Liver Failure
Hepatic Insufficiency
Liver Diseases
Brain Diseases
Rifaximin
Cirrhosis

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Rifaximin
Rifamycins
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents

ClinicalTrials.gov processed this record on December 08, 2016