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Rifaximin in Minimal Hepatic Encephalopathy

This study has been completed.
Sponsor:
Collaborator:
Salix Pharmaceuticals
Information provided by (Responsible Party):
Jasmohan Bajaj, Hunter Holmes Mcguire Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:
NCT00533910
First received: September 20, 2007
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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.

Resource links provided by NLM:

Drug Information available for: Rifaximin
U.S. FDA Resources

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 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 42
Study Start Date: October 2007
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Will be given placebo and follow the exact procedures as the experimental section
 Drug: placebo
same as the experimental arm
Experimental: Drug 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, NCT-B, ICT 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

Locations
United States, Virginia
Hunter Holmes McGuire VA Medical Center
Richmond, Virginia, United States, 23249
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

Publications:

Responsible Party: Jasmohan Bajaj, Associate Professor of Medicine, Hunter Holmes Mcguire Veteran Affairs Medical Center
ClinicalTrials.gov Identifier: NCT00533910     History of Changes
Other Study ID Numbers: PRO00006863
Study First Received: September 20, 2007
Last Updated: March 19, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Hunter Holmes Mcguire Veteran Affairs Medical Center:
Minimal hepatic encephalopathy

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 16, 2013