Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml

Condition(s) targeted: Primary Immunodeficiency

Intervention: Intravenous immunoglobulin infusion (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Sanquin

Official(s) and/or principal investigator(s):
F P Kroon, PhD, MD, Principal Investigator, Affiliation: LUMC

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.

Official title: Pharmacokinetics and Safety of the Intravenous Human Immunoglobulin Product Nanogam 100 mg/ml

Study design: Endpoint Classification: Bio-equivalence Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome:

IgG trough levels

plasma concentration-time curve

half-life

area under the curve

volume of distribution

Cmax

Tmax

elimination rate constant(s)

Secondary outcome: Adverse Events

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Jeroen Bosch Ziekenhuis, Den Bosch, Netherlands

UMCG, Groningen, Netherlands

LUMC, Leiden, Netherlands

UMC St. Radboud, Nijmegen, Netherlands

Starting date: December 2013
Last updated: April 3, 2015