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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subgam® | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subgam® (Human Normal Immunoglobulin Solution) | Biological |
|
| Measure | Description | 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) |
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Inclusion Criteria:
The main criteria for inclusion in the study were as follows:
Exclusion Criteria:
-
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Papworth Hospital | Papworth Everard | Cambridgeshire | United Kingdom | |||
| Royal Preston Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26222441 | Derived | 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. |
| Label | URL |
|---|---|
| Related Info | View source |
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| 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 |
| ID | Term |
|---|---|
| D000081207 | Primary Immunodeficiency Diseases |
| ID | Term |
|---|---|
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007153 | Immunologic Deficiency Syndromes |
| D007154 | Immune System Diseases |
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