Efficacy and Safety of IVIG-L in 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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Efficacy and Safety of IVIG-L (Human Normal Immunoglobulin for Intravenous Use)in Idiopathic Thrombocytopenic Purpura (ITP)Patients|
- 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
|Study Start Date:||October 2001|
|Estimated Study Completion Date:||March 2002|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00151840
|Hematology Clinic, Medical University of Bialystok|
|Bialystok, Poland, 15-276|
|Haematology Clinic, Medical University of Gdansk|
|Gdansk, Poland, 80-952|
|Clinic of Haematology, Medical University of Lodz|
|Lodz, Poland, 93-509|
|Clinical of Internal Diseases and haematology with Bone marrow Transplantation Unit, Central Academic Hospital, Medical Military Academy|
|Warsaw, Poland, 00-909|
|Haematology Clinic, Medical University of Warsaw|
|Warsaw, Poland, 02-097|
|Institute of Haematology and Transfusiology|
|Warsaw, Poland, 00-957|
|Study Director:||P FW Strengers, MD||Sanquin|