Kinetics, Efficacy and Safety of IVIG-L in Hypogammaglobulinemia Patients

Kinetics, Efficacy and Safety of IVIG-L (Human Normal Intravenous Immunoglobulin for Intravenous Use) in Hypogammaglobulinemia Patients

Status

Completed

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00138697

Enrollment

Registered

2005-08-30

Start date

2001-05-31

Completion date

2004-12-31

Last updated

2007-04-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypogammaglobulinemia

Keywords

Agammaglobulinemia, Hypogammaglobulinemia, Immunoglobulins, Intravenous

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.

Interventions

DRUGIVIG-L

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Kinetics of IVIG-L in patients with hypogammaglobulinemia	—
Efficacy of IVIG-L in patients with hypogammaglobulinemia	—
Safety of IVIG-L in patients with hypogammaglobulinemia	—

Secondary

Measure	Time frame
To compare the IgG trough level	—
To compare dosage and treatment intervals	—

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026