Primary Antibody Deficiency Clinical Trial
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.
| NCT number | NCT02247141 |
| Other study ID # | SCIG01 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | September 2, 2014 |
| Last updated | January 23, 2018 |
| Start date | June 2000 |
| Verified date | January 2018 |
| Source | Bio Products Laboratory |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 0 |
| Est. completion date | |
| Est. primary completion date | January 2005 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
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: |
| Country | Name | City | State |
|---|---|---|---|
| United Kingdom | Birmingham Children's Hospital | Birmingham | |
| United Kingdom | University Hospital of Wales | Cardiff | |
| United Kingdom | Guest Hospital | Dudley | West Midlands |
| 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 | Papworth Hospital | Papworth Everard | Cambridgeshire |
| United Kingdom | Royal Preston Hospital | Preston | Lancashire |
| United Kingdom | Hope Hospital | Salford | |
| United Kingdom | Northern General Hospital | Sheffield | |
| United Kingdom | Southampton General Hospital | Southampton | |
| United Kingdom | St Helier Hospital, Carshalton | Surrey |
| Lead Sponsor | Collaborator |
|---|---|
| Bio Products Laboratory |
United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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) |