Efficacy and Safety of IVIG-L in ITP Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Efficacy and Safety of IVIG-L (Human Normal Immunoglobulin for Intravenous Use)in Idiopathic Thrombocytopenic Purpura (ITP)Patients

Conditions
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Purpura, Thrombocytopenic, Idiopathic

Intervention / Treatment
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* Drug: IVIG-L


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with chronic ITP with a platelet count of about 20x109/L and at high risk of bleeding Patients with chronic ITP with a platelet count of about 20x109/L, who have to undergo surgery A stable clinical situation (no activity of any other disease) Age at least 18 yrs The patient/legally acceptable representative has signed the consent form Exclusion Criteria: The presence of another autoimmune disease related with thrombocytopenia such as systematic lupus erythematosus (SLE), rheumatoid arthritis (RA) or nephritis Patients with drug-induced thrombocytopenia or immunologic thrombocytopenia of infectious origin (in particular, Hepatitis, Epstein-Barr virus, Toxoplasma, HIV) Massive splenomegaly Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study Having an ongoing progressive terminal disease, including HIV infection Known with allergic reactions against human plasma, plasma products or intravenous immunoglobulin Presence of conditions predisposing for bleeding: anaemia (hemoglobin < 5.5 mmol/L), renal or urogenital disease, malignant disease (with the exception of basalioma, cervix carcinoma in situ), history of intracranial or aortic aneurysm, stroke, oeso-gastro-intestinal disorders with a bleeding potential, severe hypertension (diastole > 110 mm Hg). Use of corticosteroids for an acute situation within 7 days before study entry. Patients using corticosteroids prophylactically can be included Splenectomy in the previous two weeks Renal insufficiency (plasma creatinine > 115µmol/L) Pregnancy or lactation Known with insufficiency of coronary or cerebral circulation IgA deficiency and anti-IgA antibodies

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: IVIG-L|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The efficacy of IVIG-L |  |  | 
| The safety of IVIG-L |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare data on efficacy and safety of IVIG-L with data obtained from literature |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Purpura, Thrombocytopenic, Idiopathic, ITP, Immunoglobulin, Intravenous