EMBRACE: The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol
Sponsor
Alexion Pharmaceuticals (Industry)
Overall Status
Approved for marketing
CT.gov ID
NCT00438789
Collaborator
(none)
1
Study Details
Study Description
Brief Summary
The primary objective is to provide access to eculizumab for PNH patient pending commercial availability.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
Study Design
Study Type:
Expanded Access
Outcome Measures
Primary Outcome Measures
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Anthony Botti | Livingston | New Jersey | United States |
Sponsors and Collaborators
- Alexion Pharmaceuticals
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
,
,
ClinicalTrials.gov Identifier:
NCT00438789
Other Study ID Numbers:
- C06-002
First Posted:
Feb 22, 2007
Last Update Posted:
May 6, 2014
Last Verified:
Sep 1, 2011