Safety Study for Patients With a History of Hepatic Encephalopathy

This study has been completed.

Sponsor:

Information provided by:

Salix Pharmaceuticals

ClinicalTrials.gov Identifier:

NCT00686920

First received: May 27, 2008

Last updated: February 2, 2011

Last verified: February 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	May 27, 2008
Last Updated Date	February 2, 2011
Start Date ^ICMJE	March 2007
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 27, 2008)	Incidence of treatment-emergent AEs and SAEs [ Time Frame: Entire study ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00686920 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: May 27, 2008)	Changes in laboratory values, vital signs, and HE parameters [ Time Frame: Entire study ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Safety Study for Patients With a History of Hepatic Encephalopathy
Official Title ^ICMJE	Not Provided
Brief Summary	This study will look at the safety of a drug used in patients who have had hepatic encephalopathy in the past.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention
Condition ^ICMJE	Hepatic Encephalopathy
Intervention ^ICMJE	Drug: rifaximin Tablets
Study Arm (s)	Experimental: 1 Open-label safety arm Intervention: Drug: rifaximin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	500
Completion Date	Not Provided
Primary Completion Date	December 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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 HE episodes Capable and willing to comply with all study procedures. Subject has support network. Exclusion Criteria: Significant medical conditions or Investigator decision not to include. Allergies to the study drug or similar drugs. Laboratory abnormalities. Recent participation in another clinical trial Problems experienced in a previous HE trial. Pregnant or at risk of pregnancy. Recent alcohol consumption Active or latent bacterial or viral Infections Bowel issues Recent Active Cancer On a prohibited medication
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Canada

Administrative Information
NCT Number ^ICMJE	NCT00686920
Other Study ID Numbers ^ICMJE	RFHE3002
Has Data Monitoring Committee	No
Responsible Party	Michelle Widmann, Salix Pharmaceuticals
Study Sponsor ^ICMJE	Salix Pharmaceuticals
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Salix Pharmaceuticals
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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