The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol (EMBRACE)

This treatment has been approved for sale to the public.
Information provided by:
Alexion Pharmaceuticals Identifier:
First received: February 20, 2007
Last updated: September 16, 2011
Last verified: September 2011

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:

Further study details as provided by Alexion Pharmaceuticals:

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

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

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 identifier: NCT00438789

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 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, Paroxysmal
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Anemia, Hemolytic
Hematologic Diseases
Myelodysplastic Syndromes
Bone Marrow Diseases processed this record on April 15, 2014