Rifaximin in Minimal Hepatic Encephalopathy

This study is currently recruiting participants.

Verified by Hunter Holmes Mcguire Veteran Affairs Medical Center, November 2008

Sponsors and Collaborators:	Hunter Holmes Mcguire Veteran Affairs Medical Center Salix Pharmaceuticals
Information provided by:	Hunter Holmes Mcguire Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:	NCT00533910

Purpose

The purpose of this study is to determine whether alteration of gut flora with rifaximin can lead to improvement in driving performance, psychometric test performance, and quality of life in patients with minimal hepatic encephalopathy (MHE) and cirrhosis in a randomized, blinded, placebo-controlled trial.

Condition	Intervention
Hepatic Encephalopathy	Drug: Rifaximin Drug: placebo

Drug Information available for: Rifaximin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Effect of Rifaximin on Driving Performance, Psychometric Test Performance and Quality of Life in Cirrhotic Patients With Minimal Hepatic Encephalopathy: Randomized, Double-Blind, Placebo-Controlled Trial.

Further study details as provided by Hunter Holmes Mcguire Veteran Affairs Medical Center:

Primary Outcome Measures:

Driving performance [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Psychometric test performance, quality of life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	October 2007
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Placebo: Placebo Comparator Will be given placebo and follow the exact procedures as the experimental section	Drug: placebo same as the experimental arm
Drug: Experimental	Drug: Rifaximin 550mg BID rifaximin for 8 weeks

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age 18-65 years
Cirrhosis diagnosed on clinical grounds
MHE diagnosed by abnormalities in a psychometric battery (NCT-A, BDT and DST impaired beyond 2 standard deviations of known control values on any of the above 3 tests will be considered to have MHE)
Current drivers (valid driving license and driving at least 20 miles/week)
All women of child-bearing potential will be required to use effective contraception

Exclusion Criteria:

Current or recent (< 6 month) use of alcohol (AUDIT questionnaire will be used; any cirrhotic with a value of > 0 will be excluded) and a positive blood alcohol level
Use of antibiotics within last 6 weeks
Allergy to rifaximin, rifabutin, rifampin, or rifapentine
Infection or gastrointestinal hemorrhage within the last 6 weeks
Renal insufficiency
Hepatocellular carcinoma
Psychoactive drug use, including interferon concurrently
Non-drivers and those who drive less than 20 miles/week
Pregnancy and breastfeeding
Excluding patients with OHE:
- Detailed neurological examination to check for dysarthria, asterixis, ataxia and disorientation
- Detailed history-taking from friends/relatives only after taking the patient's permission
- Mini-mental status examination > 25
- Episode of overt (clinical hepatic encephalopathy) within 6 months
- Current treatment with lactulose, rifaximin, zinc, or metronidazole

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00533910

Contacts

Contact: Jasmohan S Bajaj, MBBS, MD, MS	804 675 5802	jasmohan.bajaj@va.gov
Contact: Kia Saeian, MD, MS	414-456 -6835	ksaeian@mcw.edu

Locations

United States, Virginia
Hunter Holmes McGuire VA Medical Center	Recruiting
Richmond, Virginia, United States, 23249
Principal Investigator: Jasmohan S Bajaj, MBBS, MD, MS

Sponsors and Collaborators

Hunter Holmes Mcguire Veteran Affairs Medical Center

Salix Pharmaceuticals

Investigators

Principal Investigator:

Jasmohan S Bajaj, MBBS, MD, MS

Medical College of Wisconsin

More Information

Responsible Party:	Hunter Holmes Mcguire Veteran Affairs Medical Center ( Jasmohan Bajaj )
Study ID Numbers:	PRO00006863
Study First Received:	September 20, 2007
Last Updated:	November 17, 2008
ClinicalTrials.gov Identifier:	NCT00533910
Health Authority:	United States: Food and Drug Administration

Keywords provided by Hunter Holmes Mcguire Veteran Affairs Medical Center:

Minimal hepatic encephalopathy

Study placed in the following topic categories:

Liver Diseases
Neurotoxicity Syndromes
Brain Damage, Chronic
Quality of Life
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:

Anti-Infective Agents
Therapeutic Uses
Nervous System Diseases

Gastrointestinal Agents
Central Nervous System Viral Diseases
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009