Kinetics, Efficacy and Safety of IVIG-L in Hypogammaglobulinemia Patients
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Kinetics, Efficacy and Safety of IVIG-L (Human Normal Intravenous Immunoglobulin for Intravenous Use) in Hypogammaglobulinemia Patients|
- Kinetics of IVIG-L in patients with hypogammaglobulinemia
- Efficacy of IVIG-L in patients with hypogammaglobulinemia
- Safety of IVIG-L in patients with hypogammaglobulinemia
- To compare the IgG trough level
- To compare dosage and treatment intervals
|Study Start Date:||May 2001|
|Study Completion Date:||December 2004|
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.
|Medical Centre Alkmaar|
|Alkmaar, Netherlands, 1815 JD|
|Academic Medical Centre|
|Amsterdam, Netherlands, 1100 DD|
|Academic Hospital Groningen|
|Groningen, Netherlands, 9700 RB|
|Leiden, Netherlands, 2333 ZA|
|UMC St. Radboud|
|Nijmegen, Netherlands, 6525 GA|
|The Hague, Netherlands, 2545 CH|
|Principal Investigator:||J WM van der Meer, MD, PhD||UMC St Radboud Nijmegen|