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

Bio Products Laboratory

Status and phase: Completed; Phase 3

Conditions: Primary Antibody Deficiency

Treatments: Biological: Subgam® (Human Normal Immunoglobulin Solution)

Study type: Interventional

Funder types: Other

Identifiers

NCT02247141

SCIG01

Details and patient eligibility

About

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.

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

0 participants in 1 patient group

Subgam®

Experimental group

Treatment:

Biological: Subgam® (Human Normal Immunoglobulin Solution)