A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam®
1 other identifier
interventional
N/A
1 country
14
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.
Trial Health
Trial Health Score
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14 active sites
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2000
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2005
CompletedFirst Submitted
Initial submission to the registry
September 2, 2014
CompletedFirst Posted
Study publicly available on registry
September 23, 2014
CompletedJanuary 24, 2018
January 1, 2018
4.6 years
September 2, 2014
January 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
Subgam®
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Papworth Hospital
Papworth Everard, Cambridgeshire, United Kingdom
Royal Preston Hospital
Preston, Lancashire, United Kingdom
Guest Hospital
Dudley, West Midlands, United Kingdom
Birmingham Children's Hospital
Birmingham, United Kingdom
University Hospital of Wales
Cardiff, United Kingdom
St James' University Hospital
Leeds, United Kingdom
Leicester Royal Infirmary
Leicester, United Kingdom
Great Ormond Street Hospital
London, United Kingdom
St Bartholomew's Hospital
London, United Kingdom
John Radcliffe Hospital
Oxford, United Kingdom
Hope Hospital
Salford, United Kingdom
Northern General Hospital
Sheffield, United Kingdom
Southampton General Hospital
Southampton, United Kingdom
St Helier Hospital, Carshalton
Surrey, United Kingdom
Related Publications (1)
Dash C, Gascoigne E, Gillanders K, Gooi H. Experience with Subgam, a Subcutaneously Administered Human Normal Immunoglobulin (ClinicalTrials.gov--NCT02247141). PLoS One. 2015 Jul 29;10(7):e0131565. doi: 10.1371/journal.pone.0131565. eCollection 2015.
PMID: 26222441DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2014
First Posted
September 23, 2014
Study Start
June 1, 2000
Primary Completion
January 1, 2005
Last Updated
January 24, 2018
Record last verified: 2018-01