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Safety Study for Patients With a History of Hepatic Encephalopathy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00686920
First Posted: May 30, 2008
Last Update Posted: February 3, 2011
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. Read our disclaimer for details.
Information provided by:
Valeant Pharmaceuticals International, Inc.
  Purpose
This study will look at the safety of a drug used in patients who have had hepatic encephalopathy in the past.

Condition Intervention Phase
Hepatic Encephalopathy Drug: rifaximin Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Valeant Pharmaceuticals International, Inc.:

Primary Outcome Measures:
  • Incidence of treatment-emergent AEs and SAEs [ Time Frame: Entire study ]

Secondary Outcome Measures:
  • Changes in laboratory values, vital signs, and HE parameters [ Time Frame: Entire study ]

Estimated Enrollment: 500
Study Start Date: March 2007
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Open-label safety arm
Drug: rifaximin
Tablets

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Must sign an Informed Consent Form
  • In remission from past hepatic encephalopathy (HE).
  • Appropriate birth control measures
  • More than or equal to 18 years of age.
  • Must be potential for benefit from treatment.
  • Recent HE episodes
  • Capable and willing to comply with all study procedures.
  • Subject has support network.

Exclusion Criteria:

  • Significant medical conditions or Investigator decision not to include.
  • Allergies to the study drug or similar drugs.
  • Laboratory abnormalities.
  • Recent participation in another clinical trial
  • Problems experienced in a previous HE trial.
  • Pregnant or at risk of pregnancy.
  • Recent alcohol consumption
  • Active or latent bacterial or viral Infections
  • Bowel issues
  • Recent Active Cancer
  • On a prohibited medication
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00686920


  Show 35 Study Locations
Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Michelle Widmann, Salix Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00686920     History of Changes
Other Study ID Numbers: RFHE3002
First Submitted: May 27, 2008
First Posted: May 30, 2008
Last Update Posted: February 3, 2011
Last Verified: February 2011

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
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action