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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

April 24, 2013
July 15, 2014
April 2013
July 2014   (final data collection date for primary outcome measure)
Time to first Hepatic Encephalopathy(HE) breakthrough episode [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
  • All Cause Mortality [ Time Frame: 6 Months ] [ Designated as safety issue: Yes ]
Same as current
  • 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.
Same as current
 
The 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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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
December 2014
July 2014   (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
Both
18 Years and older
No
Contact: Erica Bullock 919-862-1854 erica.bullock@salix.com
United States
 
NCT01846663
RFHE4043
Yes
Salix Pharmaceuticals
Salix Pharmaceuticals
Not Provided
Study Director: Enoch Bortey, Ph.D. Salix Pharmaceuticals
Salix Pharmaceuticals
July 2014

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