The pharmacokinetics (the behaviour in the body) and safety of the intravenous immunoglobulin product Nanogam 100 mg/ml

• Register: EUCTR
• Last refreshed on: 10 July 2015
• Main ID: EUCTR2012-005727-32-NL
• Date of registration: 23/05/2013
• Prospective Registration: Yes
• Primary sponsor: Sanquin Blood Supply Foundation
• Public title: The pharmacokinetics (the behaviour in the body) and safety of the intravenous immunoglobulin product Nanogam 100 mg/ml
• Scientific title: Pharmacokinetics and safety of the intravenous human immunoglobulin product Nanogam 100 mg/ml - PK and safety of Nanogam 100 mg/ml
• Date of first enrolment: 25/07/2013
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-005727-32
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: no Open: yes Single blind: no Double blind: no Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Nanogam 50 mg/ml versus Nanogam 100 mg/ml Number of treatment arms in the trial: 2

Countries of recruitment

Netherlands

Contacts

• Name: Medical Department
• Affiliation: Sanquin Blood Supply Foundation

• Name: Medical Department
• Affiliation: Sanquin Blood Supply Foundation

Key inclusion & exclusion 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:
- 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Immune System Diseases [C20]

Intervention(s)

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)/millilitre
Concentration type: equal
Concentration number: 100-

Trade Name: Nanogam® 50 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)/millilitre
Concentration type: equal
Concentration number: 50-

Primary Outcome(s)

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.

Main Objective: Objective of the study is to show bioequivalency between Nanogam® 50 mg/ml and Nanogam 100 mg/ml by comparing the pharmacokinetics.

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(s)

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

Secondary ID(s)

MD2012.02

Source(s) of Monetary Support

Sanquin Blood Supply Foundation