Status:
APPROVED_FOR_MARKETING
The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol
Lead Sponsor:
Alexion Pharmaceuticals, Inc.
Conditions:
Hemoglobinuria, Paroxysmal
Eligibility:
All Genders
18+ years
Brief Summary
The primary objective is to provide access to eculizumab for PNH patient pending commercial availability.
Eligibility Criteria
Inclusion
- PNH;
- At least 18 years old
- Avoid conception; and
- Willing and able to give written informed consent
Exclusion
- Active bacterial infection
- Participation in any other drug trial
- Pregnant breast feeding, or intending to conceive
- Not vaccinated against N meningitidis
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00438789
Last Update
May 6 2014
Active Locations (1)
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1
Anthony Botti
Livingston, New Jersey, United States