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

This study is currently recruiting participants.
Verified April 2017 by Valeant Pharmaceuticals International, Inc.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01846663
First Posted: May 3, 2013
Last Update Posted: April 27, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
April 24, 2013
May 3, 2013
April 27, 2017
April 3, 2013
May 2021   (Final data collection date for primary outcome measure)
Time to first Hepatic Encephalopathy(HE) breakthrough episode [ Time Frame: 6 Months ]
Same as current
Complete list of historical versions of study NCT01846663 on ClinicalTrials.gov Archive Site
  • Time to first HE-related hospitalization [ Time Frame: 6 Months ]
  • All Cause Mortality [ Time Frame: 6 Months ]
Same as current
  • Adverse Events [ Time Frame: 6 Months ]
  • Assessment of Quality of Life [ Time Frame: 6 Months ]
  • Laboratory Parameters (changes in hematology, blood chemistry and urinalysis test results) [ Time Frame: 6 Months ]
  • Vital Signs (changes in blood pressure and heart rate) [ Time Frame: 6 Months ]
  • Electrocardiograms (12 lead ECG findings) [ Time Frame: 6 months ]
  • Neurologic Function (Critical Flicker Frequency (CFF) Test) [ Time Frame: 6 Months ]
    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 ]
    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.
Same as current
 
Efficacy, Safety, And Pharmacokinetics Of Rifaximin In Subjects With Severe Hepatic Impairment And Hepatic Encephalopathy
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
The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.
Not Provided
Interventional
Phase 4
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Hepatic Encephalopathy
  • Drug: Placebo
    Placebo, oral, 0 mg BID, 6 months of treatment
  • Drug: Rifaximin
    Rifaximin, oral, 550 mg BID, 6 months treatment
    Other Name: XIFAXAN® Tablets
  • Experimental: Rifaximin
    Rifaximin, oral, 550 mg BID, 6 months of treatment
    Intervention: Drug: Rifaximin
  • Placebo Comparator: Placebo
    Placebo, oral, 0 mg BID, 6 months of treatment
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
100
June 2021
May 2021   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Erica Bullock 919-862-1854 erica.bullock@salix.com
United States
 
 
NCT01846663
RFHE4043
Yes
Not Provided
Plan to Share IPD: Yes
Valeant Pharmaceuticals International, Inc.
Valeant Pharmaceuticals International, Inc.
Not Provided
Study Director: Enoch Bortey, Ph.D. Valeant Pharmaceuticals International, Inc.
Valeant Pharmaceuticals International, Inc.
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP