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

• Status: Completed
• Trial end date: 2004-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanquin; Sanquin Plasma Products BV
• Treatments: Antibodies; Immunoglobulins

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)