Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml

Study Overview
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Brief Summary
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Intravenous immunoglobulin (IVIG) is used for treatment of a heterogeneous group of immune related disorders both as immune-replacement and immune-modulating therapy. Sanquin developed a 100 mg/ml IVIg product (Nanogam 100 mg/ml). Patient will receive one infusion with Nanogam 50 mg/ml as they used to (same dose) and subsequently 4 infusions with Nanogam 100 mg/ml (same dose). Aim is to show bioequivalency between the 50 mg/ml and the 100 mg/ml product of Sanquin.

Official Title
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Pharmacokinetics and Safety of the Intravenous Human Immunoglobulin Product Nanogam 100 mg/ml

Conditions
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Primary Immunodeficiency

Intervention / Treatment
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* Drug: Intravenous immunoglobulin infusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Primary a- or hypogammaglobulinemia, particularly patients with XLA or CVID Stabilised on treatment with Nanogam 50 mg/ml with 2-4 weeks intervals in an hospital or at home and willing to be treated with 1 infusion of Nanogam 50 mg/ml and 4 infusions of Nanogam 100 mg/ml at the hospital A stable clinical situation (no activity of any other disease; a stable immunoglobulin dose and frequency) Age >= 18 years The patient has signed the consent form Exclusion Criteria: Known with allergic reactions against human plasma or plasma products Having an ongoing progressive disease, including HIV infection Pregnancy or lactation Known with insufficiency of coronary or cerebral circulation Having renal insufficiency (plasma creatinin > 115µmol/L) Having IgA deficiency and anti-IgA antibodies have been detected

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intravenous immunoglobulin infusion<br>One intravenous infusion with Nanogam 50 mg/ml and 4 with Nanogam 100 mg/ml (0.2-0.8 g/kg) | Drug: Intravenous immunoglobulin infusion<br>* Blood samples are drawn before infusion with Nanogam 50 and Nanogam 100 mg/ml and IgG levels are determined to study PK<br>* Other names: Nanogam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IgG trough levels | Comparison IVIG 5% and 10% | before infusion | 
| plasma concentration-time curve | Comparison IVIG 5% and 10% | predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose | 
| half-life | Comparison IVIG 5% and 10% | predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose | 
| area under the curve | Comparison IVIG 5% and 10% | predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose | 
| volume of distribution | Comparison IVIG 5% and 10% | predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose | 
| Cmax | Comparison IVIG 5% and 10% | predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose | 
| Tmax | Comparison IVIG 5% and 10% | predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose | 
| elimination rate constant(s) | Comparison IVIG 5% and 10% | predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | number and type | from first till 3 weeks after last infusion (11-19 weeks dependent on infusion frequency) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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intravenous immunoglobulin, pharmacokinetics, 10% IVIG