The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol

APPROVED_FOR_MARKETING

Conditions studied: Hemoglobinuria, Paroxysmal

In brief

The primary objective is to provide access to eculizumab for PNH patient pending commercial availability.

Key facts

Study ID

NCT00438789

Run by

Alexion Pharmaceuticals, Inc.

Last updated by the study team

2014-05-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• PNH;
• At least 18 years old
• Avoid conception; and
• Willing and able to give written informed consent

You may not qualify if…

• Active bacterial infection
• Participation in any other drug trial
• Pregnant breast feeding, or intending to conceive
• Not vaccinated against N meningitidis

Where it is running

• Anthony Botti — Livingston, New Jersey, United States

Full record on ClinicalTrials.gov

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