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.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02247141

Enrollment

Unknown

Registered

2014-09-23

Start date

2000-06-30

Completion date

Unknown

Last updated

2018-01-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Primary Antibody Deficiency

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.

Interventions

BIOLOGICALSubgam® (Human Normal Immunoglobulin Solution)

Eligibility

Sex/Gender

ALL

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

Design outcomes

Primary

Measure	Time frame
Proportion of trough levels at each time point where serum IgG was more than equal to 4 g/L	Before each infusion in the first 6 months of the study (approximately 30 infusions)

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026