Back to resultsA Multi-centre Open Study to Assess the Safety and Efficacy of Subgam®
Primary Purpose
Primary Antibody Deficiency
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Subgam® (Human Normal Immunoglobulin Solution)
Sponsored by
About this trial
This is an interventional trial for Primary Antibody Deficiency
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).
Exclusion Criteria:
-
Sites / Locations
- Papworth Hospital
- Royal Preston Hospital
- Guest Hospital
- Birmingham Children's Hospital
- University Hospital of Wales
- St James' University Hospital
- Leicester Royal Infirmary
- Great Ormond Street Hospital
- St Bartholomew's Hospital
- John Radcliffe Hospital
- Hope Hospital
- Northern General Hospital
- Southampton General Hospital
- St Helier Hospital, Carshalton
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Subgam®
Arm Description
Outcomes
Primary Outcome Measures
Proportion of trough levels at each time point where serum IgG was more than equal to 4 g/L
Secondary Outcome Measures
Full Information
NCT ID
NCT02247141
First Posted
September 2, 2014
Last Updated
January 23, 2018
Sponsor
Bio Products Laboratory
1. Study Identification
Unique Protocol Identification Number
NCT02247141
Brief Title
A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam®
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
June 2000 (undefined)
Primary Completion Date
January 2005 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bio Products Laboratory
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Antibody Deficiency
7. Study Design
Study Phase
Phase 3
8. Arms, Groups, and Interventions
Arm Title
Subgam®
Arm Type
Experimental
Intervention Type
Biological
Intervention Name(s)
Subgam® (Human Normal Immunoglobulin Solution)
Primary Outcome Measure Information:
Title
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)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
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).
Exclusion Criteria:
-
Facility Information:
Facility Name
Papworth Hospital
City
Papworth Everard
State/Province
Cambridgeshire
Country
United Kingdom
Facility Name
Royal Preston Hospital
City
Preston
State/Province
Lancashire
Country
United Kingdom
Facility Name
Guest Hospital
City
Dudley
State/Province
West Midlands
Country
United Kingdom
Facility Name
Birmingham Children's Hospital
City
Birmingham
Country
United Kingdom
Facility Name
University Hospital of Wales
City
Cardiff
Country
United Kingdom
Facility Name
St James' University Hospital
City
Leeds
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
Country
United Kingdom
Facility Name
Great Ormond Street Hospital
City
London
Country
United Kingdom
Facility Name
St Bartholomew's Hospital
City
London
Country
United Kingdom
Facility Name
John Radcliffe Hospital
City
Oxford
Country
United Kingdom
Facility Name
Hope Hospital
City
Salford
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
Country
United Kingdom
Facility Name
St Helier Hospital, Carshalton
City
Surrey
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
26222441
Citation
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.
Results Reference
derived
Links:
URL
http://www.bpl.co.uk
Description
Related Info
Learn more about this trial
A Multi-centre Open Study to Assess the Safety and Efficacy of Subgam®
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