Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138697
Status:
COMPLETED
Last Update Posted:
2007-04-19
First Post:
2005-08-29
Brief Title:
Kinetics Efficacy and Safety of IVIG-L in Hypogammaglobulinemia Patients
Sponsor:
Prothya Biosolutions
Organization:
Prothya Biosolutions
Study Overview
Official Title:
Kinetics Efficacy and Safety of IVIG-L Human Normal Intravenous Immunoglobulin for Intravenous Use in Hypogammaglobulinemia Patients
Status:
COMPLETED
Status Verified Date:
2007-04
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 kinetics efficacy and safety of a liquid intravenous immunoglobulin product IVIG-L were studied in patients with hypogammaglobulinemia who are regularly treated with intravenous immunoglobulin substitution therapy
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 the infusion eliminates possible mistakes in the reconstitution with water for injections and reduces the space requirements in storage
In addition to the donor selection and donor screening several viral safety steps have been included into the production process
In this clinical trial the efficacy and safety of IVIG-L in patients with hypogammaglobulinemia who are regularly treated with intravenous immunoglobulin substitution therapy will be studied IVIG-L will also be studied in patients with chronic ITP KB98001 Data from both studies will be used for an application for marketing authorisation in Finland and the Netherlands
In addition to the donor selection and donor screening several viral safety steps have been included into the production process
In this clinical trial the efficacy and safety of IVIG-L in patients with hypogammaglobulinemia who are regularly treated with intravenous immunoglobulin substitution therapy will be studied IVIG-L will also be studied in patients with chronic ITP KB98001 Data from both studies will be used for an application for marketing authorisation 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