Conditions: Paroxysmal Nocturnal Hemoglobinuria
Keywords: Hemolytic Paroxysmal Nocturnal Hemoglobinuria Eculizumab PNH
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 27
Healthy volunteers: no

Brief summary:
The objective of this study was to assess the long-term safety and efficacy of eculizumab in hemolytic PNH patients who completed the 4-week screening and 12-week treatment period of the C07-001 study. In addition, pharmacokinetic and pharmacodynamic assessments of eculizumab were conducted.

Detailed description:

Arms:
arm 1: Treatment with eculizumab for patients with PNH who have successfully completed the C07-001 protocol

Interventions: intervention 1: Eculizumab
Intervention descriptions: intervention 1: Each vial contains 30 mL of 10 mg/mL eculizumab; dose of 900 mg intravenous every 14 days.

Protocol document: