Pharmacokinetics and Safety of IVIG Nanogam 100 mg/ml
Information source: Sanquin
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
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
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.
Clinical Details
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 levelsplasma concentration-time curve half-life area under the curve volume of distribution Cmax Tmax elimination rate constant(s)
Secondary outcome: Adverse Events
Eligibility
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
Locations and Contacts
Jeroen Bosch Ziekenhuis, Den Bosch, Netherlands
UMCG, Groningen, Netherlands
LUMC, Leiden, Netherlands
UMC St. Radboud, Nijmegen, Netherlands
Additional Information
Starting date: December 2013
Last updated: April 3, 2015
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