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The purpose of this study is to compare satisfaction (LQI questionnaire, factor I: treatment interference) in PID patients receiving subcutaneous injections of Gammanorm® 165 mg/mL according to the delivery device.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gammanorm® 165 mg/mL | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gammanorm | Biological | Sub-Q IgG |
|
| Measure | Description | Time Frame |
|---|---|---|
| "Life Quality Index" (LQI) score (factor I: treatment interference) | Primary endpoint for assessment of patient's satisfaction regarding the treatment delivery device (pump or syringe) will be the "Life Quality Index" (LQI) score (factor I: treatment interference) at the end of each 3-month treatment period. | 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boris Bienvenu, MD | Universtiy Hospital of Caen | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haut-Leveque Hospital | Bordeaux | France | ||||
| University Hospital of Caen |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29855752 | Derived | Bienvenu B, Cozon G, Mataix Y, Lachaud D, Alix A, Hoarau C, Antier D, Hachulla E, Brice S, Viallard JF, Tamisier S, Fauchais AL, Renon-Carron F, Clerson P, Fardini Y, Crave JC, Miossec P. Rapid Push vs Pump-Infused Subcutaneous Immunoglobulin Treatment: a Randomized Crossover Study of Quality of Life in Primary Immunodeficiency Patients. J Clin Immunol. 2018 May;38(4):503-512. doi: 10.1007/s10875-018-0507-x. Epub 2018 May 31. |
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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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| Caen |
| France |
| University Hospital of Lille | Lille | France |
| Hospital Dupuytren | Limoges | France |
| Clinique Mutualiste | Lyon | France |
| University Hospital of Reims | Reims | France |
| University Hospital of Toulouse | Toulouse | France |
| University Hospital of Tours | Tours | France |