Clinical trial NCT00138697: Kinetics, Efficacy and Safety of IVIG-L in Hypogammaglobulinemia Patients
Official title: Kinetics, Efficacy and Safety of IVIG-L (Human Normal Intravenous Immunoglobulin for Intravenous Use) in Hypogammaglobulinemia Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Hypogammaglobulinemia
Keywords: Agammaglobulinemia
Hypogammaglobulinemia
Immunoglobulins, Intravenous
Lead sponsor: Prothya Biosolutions
Sponsor class: INDUSTRY
First posted: 2005-08-30
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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 immunoglobulin dose)
* Age \> 18 years
* The patient/legally acceptable representative has signed the consent form

Exclusion Criteria:

* 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)

Primary outcomes:
measure: Kinetics of IVIG-L in patients with hypogammaglobulinemia
measure: Efficacy of IVIG-L in patients with hypogammaglobulinemia
measure: Safety of IVIG-L in patients with hypogammaglobulinemia
Secondary outcomes:
measure: To compare the IgG trough level
measure: To compare dosage and treatment intervals
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Medical Centre Alkmaar
city: Amsterdam
country: Netherlands
facility: Academic Medical Centre
city: Groningen
country: Netherlands
facility: Academic Hospital Groningen
city: Leiden
country: Netherlands
facility: LUMC
city: Nijmegen
country: Netherlands
facility: UMC St. Radboud
city: The Hague
country: Netherlands
facility: Leyenburg Hospital
Study officials:
affiliation: UMC St Radboud Nijmegen
name: J WM van der Meer, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: