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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-001480-36 | EudraCT Number |
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| Name | Class |
|---|---|
| Shire | INDUSTRY |
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Most immunodeficiencies are related to severe immunoglobulin deficiencies which require lifelong replacement therapy with immunoglobulin G (IgG) to reduce the incidence and severity of infections. IgG can be administered intravenously (IGIV) every 21 or 28 days or subcutaneously every week or every other week (IGSC) for subjects who do not tolerate IV infusions or have difficulties with venous access. No head-to-head data are available to directly compare HyQvia with conventional SCIG. However, SCIG is indicated for administration frequencies from daily up to every other week dosing while HyQvia is indicated for infusion frequencies every 2-4 weeks. This study is designed to assess the IgG trough level after switching from standard SCIG to every other week HyQvia and HyQvia every 3-4 weeks
Open-label, one arm study conducted in France in subjects with PI to IgG trough level at steady state after standard SCIG dosing and after HyQvia administered every other week and every 3-4 weeks at equivalent dose. The study will have three periods:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IgHy10 (HyQvia) | Experimental | Open-label, one arm study conducted in France in subjects with PI to IgG trough level at steady state after standard SCIG dosing and after IgHy10 (HyQvia) administered every other week and every 3-4 weeks at equivalent dose. The study will have three periods:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IgHy10 | Drug | Sub Cutaneous IgHy10 administration |
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| Measure | Description | Time Frame |
|---|---|---|
| The primary endpoint is the change in IgG trough level at 3 months (visit 3) as compared to baseline (visit 1). | Every 2 weeks during the baseline (visit 1) and the 3 months (visit3) |
| Measure | Description | Time Frame |
|---|---|---|
| The change in IgG trough level at 6 months (visit 4) as compared to baseline (visit 1) and 3 months (visit 3). | Every 3 weeks after the 3 months (visit 3) as 6 months ( visit 4) | |
| Number of adverse reactions | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eric Hachulla, MD, PhD | University Hospital, Lille | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU, Hôpital Claude Huriez | Lille | France | ||||
| Hôpital de la Conception |
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| 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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| Incidence rate of adverse reactions | 6 months |
| Number of infection | 6 months |
| The Short Form (36) Health Survey | standardized test for measuring the quality of life | at 6 months |
| Treatment Satisfaction Questionnaire for Medication (TSQM-9). | at 6 months |
| Marseille |
| 13005 |
| France |
| CHU de Nantes - Hôtel Dieu | Nantes | 44093 | France |
| Hôpital St Louis | Paris | 75010 | France |
| Hôpital Necker | Paris | 75015 | France |
| Hôpital Haut Lévèque | Pessac | 33604 | France |
| CHU de Strasbourg | Strasbourg | 67000 | France |