Kinetics, Efficacy and Safety of IVIG-L in Hypogammaglobulinemia Patients

Study Overview
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Brief Summary
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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.

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 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.

Official Title
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Kinetics, Efficacy and Safety of IVIG-L (Human Normal Intravenous Immunoglobulin for Intravenous Use) in Hypogammaglobulinemia Patients

Conditions
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Hypogammaglobulinemia

Intervention / Treatment
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* Drug: IVIG-L


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary a- or hypogammaglobulinemia, particularly patients with X-linked agammaglobulinemia (XLA) or Common Variable Immunodeficiency (CVID) Used to replacement treatment with intravenous immunoglobulin with 2-4 week intervals A stable clinical situation (no activity of any other disease; a stable immunoglobulin dose) Age > 18 years The patient/legally acceptable representative has signed the consent form Exclusion Criteria: Treatment with any other investigational drug within 7 days before study entry or previous enrolment in this study Known allergic reactions to human plasma or plasma products Have an ongoing progressive terminal disease, including HIV infection Pregnancy or lactation Known insufficiency of coronary or cerebral circulation Have renal insufficiency (plasma creatinine > 115µmol/L) Have an ongoing active disease causing general symptoms, e.g. chronic active hepatitis, persistent enterovirus infection. Have IgA deficiency, and anti-IgA antibodies have been detected Active systemic lupus erythematosus (SLE)

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 |
| --- | --- | --- |
| Kinetics of IVIG-L in patients with hypogammaglobulinemia |  |  | 
| Efficacy of IVIG-L in patients with hypogammaglobulinemia |  |  | 
| Safety of IVIG-L in patients with hypogammaglobulinemia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the IgG trough level |  |  | 
| To compare dosage and treatment intervals |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Agammaglobulinemia, Hypogammaglobulinemia, Immunoglobulins, Intravenous