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

Condition(s) targeted: Hypogammaglobulinemia

Intervention: IVIG-L (Drug)

Phase: Phase 2/Phase 3

Status: Completed

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

Primary outcome:

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 outcome:

To compare the IgG trough level

To compare dosage and treatment intervals

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.

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

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)

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