Ignite Creation Date:
2024-05-05 @ 11:45 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00122317
Status:
COMPLETED
Last Update Posted:
2018-03-13
First Post:
2005-07-20
Brief Title:
Extension Study of Eculizumab in Patients With Transfusion Dependent Paroxysmal Nocturnal Hemoglobinuria PNH
Sponsor:
Alexion Pharmaceuticals Inc
Organization:
Alexion Pharmaceuticals Inc
Study Overview
Official Title:
Open Label Extension Study of Eculizumab in Patients With Transfusion Dependent PNH
Status:
COMPLETED
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None