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The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol (EMBRACE)

This treatment has been approved for sale to the public.
Sponsor:
Information provided by:
Alexion Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00438789
First received: February 20, 2007
Last updated: September 16, 2011
Last verified: September 2011
History of Changes
  Purpose

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


Condition Intervention Phase
Hemoglobinuria, Paroxysmal
 Drug: eculizumab
 Phase 3

Study Type: Expanded Access     What is Expanded Access?

Resource links provided by NLM:

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: Maria Whelden, Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00438789     History of Changes
Other Study ID Numbers: C06-002
Study First Received: February 20, 2007
Last Updated: September 16, 2011
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on May 23, 2013