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: May 5, 2014
Last verified: September 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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: May 5, 2014
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 August 21, 2014