A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam®
- Conditions
- Primary Antibody Deficiency
- Interventions
- Biological: Subgam® (Human Normal Immunoglobulin Solution)
- Registration Number
- NCT02247141
- Lead Sponsor
- Bio Products Laboratory
- 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 Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- Not specified
-
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Subgam® Subgam® (Human Normal Immunoglobulin Solution) -
- Primary Outcome Measures
Name Time Method 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)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (14)
Royal Preston Hospital
🇬🇧Preston, Lancashire, United Kingdom
Papworth Hospital
🇬🇧Papworth Everard, Cambridgeshire, United Kingdom
Guest Hospital
🇬🇧Dudley, West Midlands, United Kingdom
St James' University Hospital
🇬🇧Leeds, United Kingdom
Birmingham Children's Hospital
🇬🇧Birmingham, United Kingdom
Leicester Royal Infirmary
🇬🇧Leicester, United Kingdom
Great Ormond Street Hospital
🇬🇧London, United Kingdom
Hope Hospital
🇬🇧Salford, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Southampton General Hospital
🇬🇧Southampton, United Kingdom
Northern General Hospital
🇬🇧Sheffield, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, United Kingdom
St Helier Hospital, Carshalton
🇬🇧Surrey, United Kingdom
St Bartholomew's Hospital
🇬🇧London, United Kingdom