Conditions: Paroxysmal Hemoglobinuria, Nocturnal
Keywords: transfusion dependent paroxysmal nocturnal hemoglobinuria hemolytic
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 187
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the long-term safety of eculizumab in patients with transfusion dependent hemolytic PNH.

Detailed description:
An open-label extension study to evaluate long-term safety of eculizumab in PNH patients who had completed the TRIUMPH (C04-001), SHEPHERD (C04-002), and X03-001 studies.

Arms:
arm 1: 600 mg intravenous infusion every week x 4 then 900 mg iv every two weeks

Interventions: intervention 1: eculizumab
Intervention descriptions: intervention 1: None

Protocol document: