The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol
- Conditions
- Hemoglobinuria, Paroxysmal
- Registration Number
- NCT00438789
- Lead Sponsor
- Alexion Pharmaceuticals, Inc.
- Brief Summary
The primary objective is to provide access to eculizumab for PNH patient pending commercial availability.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- APPROVED_FOR_MARKETING
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- EXPANDED_ACCESS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Anthony Botti
🇺🇸Livingston, New Jersey, United States