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The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol (EMBRACE)

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.
 
ClinicalTrials.gov Identifier: NCT00438789
Expanded Access Status : Approved for marketing
First Posted : February 22, 2007
Last Update Posted : May 6, 2014
Sponsor:
Information provided by:
Alexion Pharmaceuticals

Tracking Information
First Submitted Date February 20, 2007
First Posted Date February 22, 2007
Last Update Posted Date May 6, 2014
 
Descriptive Information
Brief Title The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol
Brief Summary The primary objective is to provide access to eculizumab for PNH patient pending commercial availability.
Detailed Description Not Provided
Study Type Expanded Access
Intervention Drug: eculizumab
600mg IV every week and 900mg IV every 2 weeks
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
Expanded Access Status Approved for marketing
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00438789
Responsible Party Maria Whelden, Alexion Pharmaceuticals
Study Sponsor Alexion Pharmaceuticals
Collaborators Not Provided
Investigators Not Provided
PRS Account Alexion Pharmaceuticals
Verification Date September 2011