Primary Immunodeficiency
Conditions
Keywords
intravenous immunoglobulin, pharmacokinetics, 10% IVIG
Brief summary
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.
Interventions
DRUGIntravenous immunoglobulin infusion
Blood samples are drawn before infusion with Nanogam 50 and Nanogam 100 mg/ml and IgG levels are determined to study PK
Sponsors
Prothya Biosolutions
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| elimination rate constant(s) | predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose | Comparison IVIG 5% and 10% |
| IgG trough levels | before infusion | Comparison IVIG 5% and 10% |
| plasma concentration-time curve | predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose | Comparison IVIG 5% and 10% |
| half-life | predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose | Comparison IVIG 5% and 10% |
| area under the curve | predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose | Comparison IVIG 5% and 10% |
| volume of distribution | predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose | Comparison IVIG 5% and 10% |
| Cmax | predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose | Comparison IVIG 5% and 10% |
| Tmax | predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose | Comparison IVIG 5% and 10% |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | from first till 3 weeks after last infusion (11-19 weeks dependent on infusion frequency) | number and type |
Countries
Netherlands
Outcome results
None listed