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

February 28, 2006
July 17, 2011
December 2005
August 2008   (final data collection date for primary outcome measure)
Time to treatment failure. [ Time Frame: Entire study ] [ Designated as safety issue: No ]
The primary efficacy endpoint is the time to treatment failure. Treatment failure is defined as an increase of the Conn score to Grade ≥2 or a Conn and asterixis score increase of 1 grade each for those subjects that have a baseline Conn Score of 0.
Complete list of historical versions of study NCT00298038 on ClinicalTrials.gov Archive Site
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A 6-month Efficacy, Safety and Tolerability Study of Rifaximin In Preventing Hepatic Encephalopathy
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

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

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Hepatic Encephalopathy
Drug: Rifaximin
550 mg tablets BID
Placebo Comparator: placebo
Intervention: Drug: Rifaximin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
299
April 2009
August 2008   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00298038
RFHE3001
Yes
Audrey Shaw, Director Clinical, Salix
Salix Pharmaceuticals
Not Provided
Study Director: William Forbes, Pharm D Salix Pharmaceuticals
Salix Pharmaceuticals
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP