The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol

• Status: Approved for marketing
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

Details

• Lead Sponsor: Alexion Pharmaceuticals
• Treatments: Eculizumab

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