A 6-month Efficacy, Safety and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy

This study has been completed.

First Received: February 28, 2006 Last Updated: December 21, 2009 History of Changes

Sponsor:	Salix Pharmaceuticals
Information provided by:	Salix Pharmaceuticals
ClinicalTrials.gov Identifier:	NCT00298038

Purpose

The purpose of this study is to determine if the study drug is safe and effective in preventing Hepatic Encephalopathy (HE).

Condition	Intervention	Phase
Hepatic Encephalopathy	Drug: Rifaximin	Phase III

Study Type:	Interventional
Study Design:	Prevention, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy, Safety and Tolerability of Rifaximin 550 mg BID For 6 Months In Preventing Hepatic Encephalopathy

Resource links provided by NLM:

Drug Information available for: Rifaximin

U.S. FDA Resources

Further study details as provided by Salix Pharmaceuticals:

Primary Outcome Measures:

Time to treatment failure. [ Time Frame: Entire study ] [ Designated as safety issue: No ]

Estimated Enrollment:	250
Study Start Date:	December 2005
Study Completion Date:	April 2009
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
placebo: Placebo Comparator	Drug: Rifaximin 550 mg tablets BID

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 prior HE episodes
Capable and willing to comply with all study procedures.
Subject has personal support available
Has a certain Model End Stage Liver Disease (MELD) score
Recent TIPS placement or revision

Exclusion Criteria:

Significant medical conditions, medical conditions that may impact study participation, or Investigator decision not to include.
Allergies to the study drug or similar drugs.
Laboratory abnormalities.
Recent participation in another clinical trial
History of non-compliance
Pregnant or at risk of pregnancy, or is lactating.
Recent alcohol consumption
Active bacterial or viral Infections
Bowel issues
Active malignancy.
On a prohibited medication.
Liver transplant expected in near term
Lactulose intolerance
Subject shows presence of intestinal obstruction or has inflammatory bowel disease.
Ongoing or recent GI bleed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00298038

Sponsors and Collaborators

Salix Pharmaceuticals

Investigators

Study Director:

William Forbes, Pharm D

Salix Pharmaceuticals Inc.

More Information

No publications provided

Responsible Party:	Salix ( Audrey Shaw, Director Clinical )
Study ID Numbers:	RFHE3001
Study First Received:	February 28, 2006
Last Updated:	December 21, 2009
ClinicalTrials.gov Identifier:	NCT00298038 History of Changes
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Anti-Infective Agents
Liver Diseases
Neurotoxicity Syndromes
Brain Damage, Chronic
Disorders of Environmental Origin
Central Nervous System Viral Diseases
Brain Diseases
Signs and Symptoms
Mental Disorders
Therapeutic Uses
Neurobehavioral Manifestations
Hepatic Insufficiency
Delirium
Liver Failure
Metabolic Diseases

Nervous System Diseases
Gastrointestinal Agents
Poisoning
Central Nervous System Diseases
Confusion
Pharmacologic Actions
Encephalitis
Virus Diseases
Hepatic Encephalopathy
Digestive System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Central Nervous System Infections
Neurologic Manifestations
Rifaximin
Brain Diseases, Metabolic

ClinicalTrials.gov processed this record on February 08, 2010