Clinical trial NCT01985373: Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml
Official title: Pharmacokinetics and Safety of the Intravenous Human Immunoglobulin Product Nanogam 100 mg/ml
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Immunodeficiency
Keywords: intravenous immunoglobulin
pharmacokinetics
10% IVIG
Lead sponsor: Prothya Biosolutions
Sponsor class: INDUSTRY
First posted: 2013-11-15
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: IgG trough levels
timeFrame: before infusion
measure: plasma concentration-time curve
timeFrame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
measure: half-life
timeFrame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
measure: area under the curve
timeFrame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
measure: volume of distribution
timeFrame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
measure: Cmax
timeFrame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
measure: Tmax
timeFrame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
measure: elimination rate constant(s)
timeFrame: predose, 1 hour, 2 hours and 1, 2, 3, 7, 14 and 21 days post-dose
Secondary outcomes:
measure: Adverse Events
timeFrame: from first till 3 weeks after last infusion (11-19 weeks dependent on infusion frequency)
Other outcomes:
Locations:
city: Den Bosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Groningen
country: Netherlands
facility: UMCG
city: Leiden
country: Netherlands
facility: LUMC
city: Nijmegen
country: Netherlands
facility: UMC St. Radboud
Study officials:
affiliation: LUMC
name: F P Kroon, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References: