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

  Show 28 Study Locations
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
Brain Diseases, Metabolic
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Metabolic Diseases
Rifaximin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 18, 2014