Kinetics, Efficacy and Safety of IVIG-L in Hypogammaglobulinemia Patients
Information source: Sanquin
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hypogammaglobulinemia
Intervention: IVIG-L (Drug)
Phase: Phase 2/Phase 3
Sponsored by: Sanquin
Official(s) and/or principal investigator(s):
J WM van der Meer, MD, PhD, Principal Investigator, Affiliation: UMC St Radboud Nijmegen
The kinetics, efficacy and safety of a liquid intravenous immunoglobulin product, IVIG-L,
were studied in patients with hypogammaglobulinemia, who are regularly treated with
intravenous immunoglobulin substitution therapy.
Official title: Kinetics, Efficacy and Safety of IVIG-L (Human Normal Intravenous Immunoglobulin for Intravenous Use) in Hypogammaglobulinemia Patients
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Kinetics of IVIG-L in patients with hypogammaglobulinemia
Efficacy of IVIG-L in patients with hypogammaglobulinemia
Safety of IVIG-L in patients with hypogammaglobulinemia
To compare the IgG trough level
To compare dosage and treatment intervals
Sanquin has developed, in cooperation with the Finnish Red Cross Blood Transfusion Service
(FRCBTS), a liquid intravenous immunoglobulin product, IVIG-L. The liquid formulation of
intravenous immunoglobulin simplifies the infusion, eliminates possible mistakes in the
reconstitution with water for injections and reduces the space requirements in storage.
In addition to the donor selection and donor screening, several viral safety steps have been
included into the production process.
In this clinical trial, the efficacy and safety of IVIG-L in patients with
hypogammaglobulinemia, who are regularly treated with intravenous immunoglobulin
substitution therapy, will be studied. IVIG-L will also be studied in patients with chronic
ITP (KB98001). Data from both studies will be used for an application for marketing
authorisation in Finland and the Netherlands.
Minimum age: 18 Years.
Maximum age: N/A.
- Primary a- or hypogammaglobulinemia, particularly patients with X-linked
agammaglobulinemia (XLA) or Common Variable Immunodeficiency (CVID)
- Used to replacement treatment with intravenous immunoglobulin with 2-4 week intervals
- A stable clinical situation (no activity of any other disease; a stable
- Age > 18 years
- The patient/legally acceptable representative has signed the consent form
- Treatment with any other investigational drug within 7 days before study entry or
previous enrolment in this study
- Known allergic reactions to human plasma or plasma products
- Have an ongoing progressive terminal disease, including HIV infection
- Pregnancy or lactation
- Known insufficiency of coronary or cerebral circulation
- Have renal insufficiency (plasma creatinine > 115µmol/L)
- Have an ongoing active disease causing general symptoms, e. g. chronic active
hepatitis, persistent enterovirus infection.
- Have IgA deficiency, and anti-IgA antibodies have been detected
- Active systemic lupus erythematosus (SLE)
Locations and Contacts
Medical Centre Alkmaar, Alkmaar 1815 JD, Netherlands
Academic Medical Centre, Amsterdam 1100 DD, Netherlands
Academic Hospital Groningen, Groningen 9700 RB, Netherlands
LUMC, Leiden 2333 ZA, Netherlands
UMC St. Radboud, Nijmegen 6525 GA, Netherlands
Leyenburg Hospital, The Hague 2545 CH, Netherlands
Starting date: May 2001
Last updated: April 18, 2007