Ignite Creation Date:
2024-05-05 @ 5:18 PM
Last Modification Date:
2024-10-26 @ 9:30 AM
Study NCT ID:
NCT00426270
Status:
COMPLETED
Last Update Posted:
2014-08-01
First Post:
2007-01-22
Brief Title:
Clinical Study to Evaluate the Efficacy and Safety of Octagam 10 in Idiopathic Thrombocytopenic Purpura in Adults
Sponsor:
Octapharma
Organization:
Octapharma
Study Overview
Official Title:
Clinical Study to Evaluate the Efficacy and Safety of Octagam 10 in Idiopathic Thrombocytopenic Purpura in Adults
Status:
COMPLETED
Status Verified Date:
2014-07
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:
Octagam is a solventdetergent-treated human normal immunoglobulin IGIV solution for intravenous administration Octagam 5 is currently registered in about 80 countries This study evaluated the efficacy and safety of Octagam 10 in Idiopathic Thrombocytopenic Purpura ITP in adults As Octagam 10 is essentially similar to Octagam 5 it is expected that Octagam 10 is as efficacious and safe in respect to viral safety as Octagam 5
Detailed Description:
The primary objective of the study was to investigate the efficacy of Octagam 10 in correcting platelet count The blood count as well as laboratory chemistry were checked repeatedly up to day 21
The secondary objective of the study was to investigate the safety of Octagam 10 Safety was assessed by monitoring vital signs evaluating adverse events assessing laboratory parameters and by viral safety testing
The secondary objective of the study was to investigate the safety of Octagam 10 Safety was assessed by monitoring vital signs evaluating adverse events assessing laboratory parameters and by viral safety testing
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