We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol (EMBRACE)

This treatment has been approved for sale to the public.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00438789
First Posted: February 22, 2007
Last Update Posted: May 6, 2014
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.
Information provided by:
Alexion Pharmaceuticals
  Purpose
The primary objective is to provide access to eculizumab for PNH patient pending commercial availability.

Condition Intervention
Hemoglobinuria, Paroxysmal Drug: eculizumab

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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 ClinicalTrials.gov identifier (NCT number): NCT00438789


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

Responsible Party: Maria Whelden, Alexion Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00438789     History of Changes
Other Study ID Numbers: C06-002
First Submitted: February 20, 2007
First Posted: February 22, 2007
Last Update Posted: May 6, 2014
Last Verified: September 2011

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