Primary a- or hypogammaglobulinemia MedDRA version: 14.1 Level: LLT Classification code 10010112 Term: Common variable immunodeficiency System Organ Class: 100000004870 MedDRA version: 14.1 Level: LLT Classification code 10010509 Term: Congenital hypogammaglobulinemia System Organ Class: 100000004850 MedDRA version: 14.1 Level: LLT Classification code 10071133 Term: Congenital agammaglobulinemia System Organ Class: 100000004850
Conditions
Interventions
Product Name: Nanogam 100 mg/ml
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Other descriptive name: IVIG
Concentration unit: mg/ml milligram(s)/mil
Sponsors
Sanquin Blood Supply Foundation
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Primary a- or hypogammaglobulinemia, particularly patients with XLA or CVID - Stabilised on treatment with Nanogam® 50 mg/ml with 3-4 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 and older - The patient/legally acceptable representative has signed the consent form Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 |
|---|---|
| Main Objective: Objective of the study is to show bioequivalency between Nanogam® 50 mg/ml and Nanogam 100 mg/ml by comparing the pharmacokinetics.;Secondary Objective: The secondary objective of this study is to study the safety and tolerability of Nanogam 100 mg/ml by recording of both local and systemic adverse events.;Primary end point(s): In the pharmacokinetic part of the study plasma concentration-time curve, half-life, area under the curve (AUC), volume of distribution (Vd), Cmax, Tmax, and elimination rate constant(s) are calculated. PK parameters obtained with Nanogam® 50 mg/ml and Nanogam 100 mg/ml will be compared.;Timepoint(s) of evaluation of this end point: Serum IgG levels are measured before and directly after infusion (within 5 min) and 1 hour, 2 hours, 1, 2, 3, 7, 14 and 21 days after infusion. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Safety will be monitored by measuring vital signs (blood pressure, heart rate, temperature) and recording all adverse events during and after the infusions (type and number). All adverse events will be analysed regarding to causality, seriousness, outcome and expectedness. ;Timepoint(s) of evaluation of this end point: During study period | — |
Countries
Netherlands
Contacts
Public ContactMedical Department
Sanquin Blood Supply Foundation
Outcome results
None listed