A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam®

A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam® Given Via the Subcutaneous Route in Primary Antibody Deficient Patients.

The primary objective was to determine the efficacy of Human Normal Immunoglobulin (Subgam®) given subcutaneously by weekly infusion to patients with primary antibody deficiency.

The secondary objective was to determine the safety of Subgam® given subcutaneously by weekly infusion to patients with primary antibody deficiency.

Inclusion Criteria:

• The main criteria for inclusion in the study were as follows:

  • A diagnosis of primary antibody deficiency;
  • No lower or upper age limit (any age was eligible);
  • With stable disease and receiving immunoglobulin (IVIG or SCIG) therapy for at least six months prior to starting the study;
  • Written informed consent (patient/parent/guardian).

Exclusion Criteria:

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