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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.
See Contacts and Locations
Verified April 2017 by Valeant Pharmaceuticals International, Inc.
Sponsor:
Information provided by (Responsible Party):
Valeant Pharmaceuticals International, Inc.
ClinicalTrials.gov Identifier:
NCT01846663
First received: April 24, 2013
Last updated: April 26, 2017
Last verified: April 2017
  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
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Time to first HE-related hospitalization [ Time Frame: 6 Months ]
  • All Cause Mortality [ Time Frame: 6 Months ]

Other Outcome Measures:
  • 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.


Estimated Enrollment: 100
Actual Study Start Date: April 3, 2013
Estimated Study Completion Date: June 2021
Estimated Primary Completion Date: May 2021 (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)
Sexes Eligible for Study:   All
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
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: April 26, 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Valeant Pharmaceuticals International, Inc.:
Hepatic Encephalopathy
Liver Failure
Hepatic Insufficiency
Liver Diseases
Brain Diseases
Rifaximin
Cirrhosis

Additional relevant MeSH terms:
Hepatic Encephalopathy
Brain Diseases
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 September 20, 2017