The Paroxysmal Nocturnal Hemoglobinuria Early Access Treatment Protocol (EMBRACE)

Alexion Pharmaceuticals

Status

Conditions: Hemoglobinuria, Paroxysmal

Treatments: Drug: eculizumab

Study type: Expanded Access

Funder types: Industry

Identifiers

NCT00438789

C06-002

Details and patient eligibility

About

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

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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