The pharmacokinetics (the behaviour in the body) and safety of the intravenous immunoglobulin product Nanogam 100 mg/ml
- Conditions
- Primary a- or hypogammaglobulinemiaMedDRA version: 14.1Level: LLTClassification code 10010112Term: Common variable immunodeficiencySystem Organ Class: 100000004870MedDRA version: 14.1Level: LLTClassification code 10010509Term: Congenital hypogammaglobulinemiaSystem Organ Class: 100000004850MedDRA version: 14.1Level: LLTClassification code 10071133Term: Congenital agammaglobulinemiaSystem Organ Class: 100000004850Therapeutic area: Diseases [C] - Immune System Diseases [C20]
- Registration Number
- EUCTR2012-005727-32-NL
- Lead Sponsor
- Sanquin Blood Supply Foundation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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