Safety Study for Patients With a History of Hepatic Encephalopathy

This study is currently recruiting participants.

Verified by Salix Pharmaceuticals, May 2008

Sponsored by:	Salix Pharmaceuticals
Information provided by:	Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00686920

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 III

Drug Information available for: Rifaximin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:

Incidence of treatment-emergent AEs and SAEs [ Time Frame: Entire study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Changes in laboratory values, vital signs, and HE parameters [ Time Frame: Entire study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	500
Study Start Date:	March 2007
Estimated Primary Completion Date:	September 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Open-label saftey arm	Drug: rifaximin Tablets

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00686920

Contacts

Contact: Audrey Shaw, Ph.D.

919-862-1000

audrey.shaw@salix.com

Locations

United States, New York
New York University School of Medicine	Recruiting
New York, New York, United States, 10016
Contact: Christelle Sommervil 212-263-8391

Sponsors and Collaborators

Salix Pharmaceuticals

More Information

Responsible Party:	Salix Pharmaceuticals ( Audrey Shaw, Director Clinical Research )
Study ID Numbers:	RFHE3002
Study First Received:	May 27, 2008
Last Updated:	July 26, 2008
ClinicalTrials.gov Identifier:	NCT00686920
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Liver Diseases
Neurotoxicity Syndromes
Brain Damage, Chronic
Disorders of Environmental Origin
Brain Diseases
Signs and Symptoms
Mental Disorders
Brain Injuries
Dementia
Neurobehavioral Manifestations
Hepatic Insufficiency
Delirium
Liver Failure
Metabolic Diseases
Neurotoxicity syndromes

Poisoning
Central Nervous System Diseases
Confusion
Encephalitis
Cognition Disorders
Virus Diseases
Hepatic Encephalopathy
Digestive System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Central Nervous System Infections
Neurologic Manifestations
Rifaximin
Metabolic disorder
Brain Diseases, Metabolic

Additional relevant MeSH terms:

Nervous System Diseases
Central Nervous System Viral Diseases

ClinicalTrials.gov processed this record on January 16, 2009