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

Brief Summary:
The primary objective is to provide access to eculizumab for PNH patient pending commercial availability.

Condition or disease Intervention/treatment
Hemoglobinuria, Paroxysmal Drug: eculizumab

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Study Type : Expanded Access

Intervention Details:
  • Drug: eculizumab
    600mg IV every week and 900mg IV every 2 weeks

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

Inclusion Criteria:

  • PNH;
  • At least 18 years old
  • Avoid conception; and
  • Willing and able to give written informed consent

Exclusion Criteria:

  • Active bacterial infection
  • Participation in any other drug trial
  • Pregnant breast feeding, or intending to conceive
  • Not vaccinated against N meningitidis

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): NCT00438789

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United States, New Jersey
Anthony Botti
Livingston, New Jersey, United States
Sponsors and Collaborators
Alexion Pharmaceuticals
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Responsible Party: Maria Whelden, Alexion Pharmaceuticals Identifier: NCT00438789    
Other Study ID Numbers: C06-002
First Posted: February 22, 2007    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: September 2011
Additional relevant MeSH terms:
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Hemoglobinuria, Paroxysmal
Urination Disorders
Urologic Diseases
Urological Manifestations
Anemia, Hemolytic
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs