Hypogammaglobulinemia Clinical Trial
Official title:
Kinetics, Efficacy and Safety of IVIG-L (Human Normal Intravenous Immunoglobulin for Intravenous Use) 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.
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.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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