Title
E07-001: Safety and Efficacy Extension Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients
Phase II Clinical Study of Eculizumab (h5G1.1-mAb) in Hemolytic Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients: Extension Study to C07-001 Protocol
Phase
Phase 2Lead Sponsor
AlexionStudy Type
InterventionalStatus
Completed Results PostedIndication/Condition
Paroxysmal Nocturnal HemoglobinuriaIntervention/Treatment
eculizumab ...Study Participants
27The 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.
Each vial contains 30 mL of 10 mg/mL eculizumab; dose of 900 mg intravenous every 14 days.
Treatment with eculizumab for patients with PNH who have successfully completed the C07-001 protocol
Inclusion Criteria: Patients must have fully completed C07-001 study 12-week treatment period Exclusion Criteria: Patients who terminated early from the C07-001 study
| Event Type | Organ System | Event Term | Eculizumab |
|---|
The FACIT-Fatigue scale, Version 4.0, is a collection of quality of life questionnaires pertaining to the management of fatigue symptoms due to a chronic illness. The FACIT-Fatigue is a 13-item questionnaire that assesses self-reported fatigue and its impact upon daily activities and function over the preceding 7 days. Patients score each item on a 5-point scale: 0 (Not at all) to 4 (Very much). Total scores range from 0 to 52, with higher score indicating better quality of life.
Baseline is defined as the number of units transfused in 3 months prior to baseline
