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The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol (EMBRACE)
This treatment has been approved for sale to the public.
First Received: February 20, 2007   Last Updated: April 22, 2008   History of Changes
Sponsored by: Alexion Pharmaceuticals
Information provided by: Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00438789
  Purpose

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


Condition Intervention Phase
Hemoglobinuria, Paroxysmal
 Drug: eculizumab
 Phase III

Study Type: Expanded Access

Resource links provided by NLM:

Genetics Home Reference related topics: paroxysmal nocturnal hemoglobinuria
Drug Information available for: Eculizumab
U.S. FDA Resources

Further study details as provided by Alexion Pharmaceuticals:

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00438789

Locations
United States, New Jersey
Anthony Botti
Livingston, New Jersey, United States
Sponsors and Collaborators
Alexion Pharmaceuticals
  More Information

No publications provided

Responsible Party: Alexion Pharmaceuticals ( Maria Whelden )
Study ID Numbers: C06-002
Study First Received: February 20, 2007
Last Updated: April 22, 2008
ClinicalTrials.gov Identifier: NCT00438789     History of Changes
Health Authority: United States: Food and Drug Administration

Study placed in the following topic categories:
Urination Disorders
Hematologic Diseases
Myelodysplastic Syndromes
Anemia
Marchiafava-Micheli Disease
Anemia, Hemolytic
Hemoglobinuria
 Signs and Symptoms
Proteinuria
Preleukemia
Paroxysmal Nocturnal Hemoglobinuria
Urologic Diseases
Hemoglobinuria, Paroxysmal
Bone Marrow Diseases

Additional relevant MeSH terms:
Signs and Symptoms
Urological Manifestations
Hemoglobinuria
Proteinuria
Urologic Diseases
Hematologic Diseases
 Urination Disorders
Myelodysplastic Syndromes
Anemia
Hemoglobinuria, Paroxysmal
Anemia, Hemolytic
Bone Marrow Diseases

ClinicalTrials.gov processed this record on September 10, 2009



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