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

This study has been completed.
Sponsor:
Information provided by:
Salix Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00298038
First received: February 28, 2006
Last updated: July 17, 2011
Last verified: July 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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):
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 July 29, 2014