Ignite Creation Date:
2024-05-05 @ 6:35 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00504075
Status:
COMPLETED
Last Update Posted:
2013-03-01
First Post:
2007-07-18
Brief Title:
A Study to Find How Safe and Effective GAMMAPLEX is in Subjects With Chronic Idiopathic Thrombocytopenic Purpura ITP
Sponsor:
Bio Products Laboratory
Organization:
Bio Products Laboratory
Study Overview
Official Title:
A Phase III Multicenter Open-Label Study To Evaluate the Efficacy and Safety of GAMMAPLEX in Chronic Idiopathic Thrombocytopenic Purpura
Status:
COMPLETED
Status Verified Date:
2013-02
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:
To determine if GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109L similar to that of published response 60 Also to assess the safety of GAMMAPLEX and determine if platelet counts are maintained at 50 x 109L in subjects with chronic ITP for
Detailed Description:
The primary objective is to determine if BPLs GAMMAPLEX raises the platelet count of subjects with chronic ITP to a threshold of 50 x 109L similar to that of published response 60 The secondary objectives are 1 to determine the safety of GAMMAPLEX at the dosage used in this study 2 to determine if GAMMAPLEX maintains platelet counts of ³ 50 x 109L in subjects with chronic ITP for a period of time similar to that of a published data
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