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

Bio Products Laboratory14 sites in 1 countryJune 2000

ConditionsPrimary Antibody Deficiency

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Primary Antibody Deficiency
Sponsor: Bio Products Laboratory
Locations: 14
Primary Endpoint: Proportion of trough levels at each time point where serum IgG was more than equal to 4 g/L
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2000

End Date

January 2005

Last Updated

8 years ago

Study Type

Interventional

Sex

All

Investigators

Sponsor

Bio Products Laboratory

Responsible Party

Sponsor

Eligibility Criteria

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).