The primary objective is to examine the pharmacokinetics of Nanogam 100 mg/ml and compare these with Nanogam 50 mg/ml. The secondary objective is safety and tolerability of Nanogam 100 mg/ml. Aim is to show bioequivalency between Nanogam 50 mg/ml…
ID
Source
Brief title
Condition
- Immune system disorders congenital
- Immunodeficiency syndromes
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study parameters are the 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 the
Nanogam 50 mg/ml and Nanogam 100 mg/ml will be compared.
Secondary outcome
Safety will be monitored by measuring vital signs and recording all adverse
events during and after the infusions (number and type).
Background summary
Intravenous immunoglobulin (IVIG) is used for treatment of a heterogeneous
group of immune related diseases both in immune-replacement therapy and in
immune-modulating disorders. Sanquin developed a 100 mg/ml IVIg product
manufactured according to the Nanogam 50 mg/ml process.
Study objective
The primary objective is to examine the pharmacokinetics of Nanogam 100 mg/ml
and compare these with Nanogam 50 mg/ml. The secondary objective is safety and
tolerability of Nanogam 100 mg/ml. Aim is to show bioequivalency between
Nanogam 50 mg/ml and Nanogam 100 mg/ml.
Study design
The study is a prospective, open-label, cross-over, multicentre trail.
Intervention
Patients will receive one intravenous infusion with Nanogam 50 mg/ml as they
used to and four infusions of Nanogam 100 mg/ml at frequency and dose as their
regular treatment with Nanogam 50 mg/ml.
Study burden and risks
Patients are already stabilised on treatment with Nanogam 50 mg/ml. Patients
will receive one intravenous infusion with Nanogam 50 mg/ml as they used to and
four intravenous infusions with Nanogam 100 mg/ml at the frequency and dose as
their regular treatment. Since both products are the same except for the
protein concentration, no extra risks are expected. Patients who used to be
treated via the home treatment service have to visit the hospital to be treated
with the study medication. Extra blood samples will be taken. Prior to each
infusion a blood sample (5 ml) is taken to determine IgG trough level. After
the first (Nanogam 50 mg/ml) and the fifth infusion (Nanogam 100 mg/ml) blood
samples for pharmacokinetic analysis (9 times 5 ml) are drawn directly after
infusion and 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days after infusion.
Patients will be asked to stay in the hospital till 2 hours after infusion for
two blood samplings. Haematology and clinical chemistry variables will be
determined before and directly after each infusion with Nanogam 100 mg/ml (2x
10 ml). Extra renal function (serum creatinin) (2 ml) will be monitored on day
1, 2 and 3 after the fifth infusion. Vital signs are measured before infusion,
and 30 min, 60 min and thereafter with one-hour intervals during the infusion
and directly after the infusion with Nanogam 100 mg/ml. A pre-treatment serum
and EDTA-plasma sample (5 ml each) before the first Nanogam 100 mg/ml infusion
will be stored at -70 ºC by Sanquin for possible future testing of virus
infection.
Plesmanlaan 125
Amsterdam 1066CX
NL
Plesmanlaan 125
Amsterdam 1066CX
NL
Listed location countries
Age
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 or older
- 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
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| EudraCT | EUCTR2012-005727-32-NL |
| CCMO | NL43002.058.13 |