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