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| ID | Type | Description | Link |
|---|---|---|---|
| 2012-005727-32 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous immunoglobulin infusion | Experimental | One intravenous infusion with Nanogam 50 mg/ml and 4 with Nanogam 100 mg/ml (0.2-0.8 g/kg) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous immunoglobulin infusion | Drug | Blood samples are drawn before infusion with Nanogam 50 and Nanogam 100 mg/ml and IgG levels are determined to study PK |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | number and type | from first till 3 weeks after last infusion (11-19 weeks dependent on infusion frequency) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| F P Kroon, PhD, MD | LUMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | Netherlands | ||||
| UMCG |
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| ID | Term |
|---|---|
| D000081207 | Primary Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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|
| Groningen |
| Netherlands |
| LUMC | Leiden | Netherlands |
| UMC St. Radboud | Nijmegen | Netherlands |