Purpura, Thrombocytopenic, Idiopathic Clinical Trial
Official title:
Efficacy and Safety of IVIG-L (Human Normal Immunoglobulin for Intravenous Use)in Idiopathic Thrombocytopenic Purpura (ITP)Patients
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.
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 hypogammaglobulinemia.The results from both studies will be used for an
application for marketing authorisation of IVIG-L in Finland and the Netherlands.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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