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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00298038
Recruitment Status : Completed
First Posted : March 1, 2006
Last Update Posted : July 19, 2011
Information provided by:
Valeant Pharmaceuticals International, Inc.

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

Condition or disease Intervention/treatment Phase
Hepatic Encephalopathy Drug: Rifaximin Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 299 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : December 2005
Actual Primary Completion Date : August 2008
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Rifaximin

Arm Intervention/treatment
Placebo Comparator: placebo Drug: Rifaximin
550 mg tablets BID

Primary Outcome Measures :
  1. Time to treatment failure. [ Time Frame: Entire study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00298038

Sponsors and Collaborators
Valeant Pharmaceuticals International, Inc.
Study Director: William Forbes, Pharm D Valeant Pharmaceuticals International, Inc.

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Audrey Shaw, Director Clinical, Salix Identifier: NCT00298038     History of Changes
Other Study ID Numbers: RFHE3001
First Posted: March 1, 2006    Key Record Dates
Last Update Posted: July 19, 2011
Last Verified: July 2011

Additional relevant MeSH terms:
Brain Diseases
Hepatic Encephalopathy
Central Nervous System Diseases
Nervous System Diseases
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Brain Diseases, Metabolic
Metabolic Diseases
Anti-Infective Agents
Gastrointestinal Agents
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents