Ignite Creation Date:
2024-05-05 @ 6:36 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00511147
Status:
COMPLETED
Last Update Posted:
2017-06-12
First Post:
2007-08-01
Brief Title:
IGIV Study for Chronic ITP Patients Ages 3-70
Sponsor:
Grifols Biologicals LLC
Organization:
Grifols Biologicals LLC
Study Overview
Official Title:
A Multi-center Prospective Open-label Clinical Trial to Assess the Safety and the Efficacy of a New Intravenous Immune Globulin IGIV3I Grifols 10 in Patients With Idiopathic Immune Thrombocytopenic Purpura
Status:
COMPLETED
Status Verified Date:
2017-05
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:
Idiopathic immune thrombocytopenic purpura ITP is an autoimmune disorder characterized by platelet destruction and thrombocytopenia peripheral blood platelet count 150 x 109L IVIG therapy is useful in patients in whom the platelet count has to be raised either due to bleeding signs or where bleeding is predicted eg surgery or parturition The primary goal of treatment is to maintain the platelet count at a hemostatic level This study will test the safety and efficacy of IGIV3I Grifols 10 in the treatment of patients with chronic ITP
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None