Ignite Creation Date:
2024-05-05 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00151840
Status:
COMPLETED
Last Update Posted:
2006-01-31
First Post:
2005-09-08
Brief Title:
Efficacy and Safety of IVIG-L in ITP Patients
Sponsor:
Prothya Biosolutions
Organization:
Prothya Biosolutions
Study Overview
Official Title:
Efficacy and Safety of IVIG-L Human Normal Immunoglobulin for Intravenous Usein Idiopathic Thrombocytopenic Purpura ITPPatients
Status:
COMPLETED
Status Verified Date:
2006-01
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 efficacy and safety of a liquid intravenous immunoglobulin product IVIG-L in patients with ITP will be assessed and compared with data obtained from literature
Detailed Description:
Sanquin has developed in cooperation with the Finnish Red Cross Blood Transfusion Service FRCBTS a liquid intravenous immunoglobulin product IVIG-L The liquid formulation of intravenous immunoglobulin simplifies infusion eliminates possible mistakes in the reconstitution with water for injection and reduces space requirements in storage
In addition to donor selection and screening several procedures have been included in the production process to improve viral safety
In this clinical trial the efficacy and safety of IVIG-L in patients with ITP will be assessed and compared with data obtained from literature IVIG-L will also be studied in patients with hypogammaglobulinemiaThe results from both studies will be used for an application for marketing authorisation of IVIG-L in Finland and the Netherlands
In addition to donor selection and screening several procedures have been included in the production process to improve viral safety
In this clinical trial the efficacy and safety of IVIG-L in patients with ITP will be assessed and compared with data obtained from literature IVIG-L will also be studied in patients with hypogammaglobulinemiaThe results from both studies will be used for an application for marketing authorisation of IVIG-L in Finland and the Netherlands
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