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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief Summary:

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.

Detailed Summary:
Sponsor: Bio Products Laboratory

Current Primary Outcome: Proportion of trough levels at each time point where serum IgG was more than equal to 4 g/L [ Time Frame: Before each infusion in the first 6 months of the study (approximately 30 infusions) ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Bio Products Laboratory

Dates:
Date Received: September 2, 2014
Date Started: June 2000
Date Completion:
Last Updated: September 19, 2014
Last Verified: August 2014