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

Prothya Biosolutions

Status and phase

Completed

Phase 3

Phase 2

Conditions

Hypogammaglobulinemia

Treatments

Drug: IVIG-L

Study type

Interventional

Funder types

Industry

Identifiers

NCT00138697

KB97003 (A & B)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No 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)