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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
Hematology Clinic, Medical University of Bialystok
Bialystok, Poland
Haematology Clinic, Medical University of Gdansk
Gdansk, Poland
Clinic of Haematology, Medical University of Lodz
Lodz, Poland
Clinical of Internal Diseases and haematology with Bone marrow Transplantation Unit, Central Academic Hospital, Medical Military Academy
Warsaw, Poland
The efficacy of IVIG-L
The safety of IVIG-L
To compare data on efficacy and safety of IVIG-L with data obtained from literature
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Institute of Haematology and Transfusiology
Warsaw, Poland
Haematology Clinic, Medical University of Warsaw
Warsaw, Poland