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

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 3

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: Prevention
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 ]

Enrollment:	299
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 Comparator: placebo	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

More Information

No publications provided by Salix Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Sanyal A, Younossi ZM, Bass NM, Mullen KD, Poordad F, Brown RS, Vemuru RP, Mazen Jamal M, Huang S, Merchant K, Bortey E, Forbes WP. Randomised clinical trial: rifaximin improves health-related quality of life in cirrhotic patients with hepatic encephalopathy - a double-blind placebo-controlled study. Aliment Pharmacol Ther. 2011 Oct;34(8):853-61. Epub 2011 Aug 17.

Bass NM, Mullen KD, Sanyal A, Poordad F, Neff G, Leevy CB, Sigal S, Sheikh MY, Beavers K, Frederick T, Teperman L, Hillebrand D, Huang S, Merchant K, Shaw A, Bortey E, Forbes WP. Rifaximin treatment in hepatic encephalopathy. N Engl J Med. 2010 Mar 25;362(12):1071-81.

Responsible Party:	Audrey Shaw, Director Clinical, Salix
ClinicalTrials.gov Identifier:	NCT00298038 History of Changes
Other Study ID Numbers:	RFHE3001
Study First Received:	February 28, 2006
Last Updated:	July 17, 2011
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Hepatic Encephalopathy
Brain Damage, Chronic
Delirium
Encephalitis
Neurotoxicity Syndromes
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Metabolic Diseases
Confusion

Neurobehavioral Manifestations
Neurologic Manifestations
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Central Nervous System Viral Diseases
Virus Diseases
Central Nervous System Infections
Poisoning
Substance-Related Disorders
Rifaximin
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents

ClinicalTrials.gov processed this record on May 22, 2013