Effect of Subcutaneous Immunoglobulin (IgSC) Gammanorm® on the Distribution of IgG Subclasses and on the Humoral Immunity of Patients With Secondary Immunodeficiency.
| Registry | NCT03369301 |
|---|---|
| Status | Completed |
| Study type | Observational |
| Enrollment | 102 (Actual) |
| Sponsor | Octapharma (Industry) |
| Conditions | Secondary Immune Deficiency |
| Interventions | Gammanorm, Other Subcutaneous Immunoglobulins (Drug) |
| Dates | start 2017-09-25, primary completion 2019-11-22, completion 2019-11-22, first posted 2017-12-12, last updated 2022-03-02 |
| Locations | 6 sites in France |
Related Papers Related Patents Related Grants Related Experts
All trials for Secondary Immune Deficiency All trials of Gammanorm All trials of Other Subcutaneous Immunoglobulins
Patients with Myeloma or CLL with severe secondary hypogammaglobinemia and recurrent infections will be included in this study; for whom an IgSC treatment was prescribed. The IgSC prescription will be the decision of the treating physician. Patient care and follow up will be performed according to the current clinical practice and the recommendations of HAS.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Gammanorm | Drug: Gammanorm | Patients on Gammanorm per standard of care | |
| Other Subcutaneous Immunoglobulin | Drug: Other Subcutaneous Immunoglobulins | Patients on subcutaneous immunoglobulin treatments other than Gammanorm |
Sex: All, ages: 18 Years to any
Inclusion Criteria: 1. Adult male or female (≥18 years old), Myeloma or Chronic Lymphocytic Leukemia patients with secondary hypogammaglobinemia and recurring infections. 2. Patients with indication for IgSC treatment but who have not started the treatment yet. Prior IgSC or IgIV treatment 6 months before inclusion is accepted (with a washout period of 6 months minimum). 3. Patient having received all the necessary information about the study and signed an informed consent document. Exclusion Criteria: 1. Patient having initiated an IgSC treatment. 2. Patient having received IgSC or IgIV treatment within 6 months prior to inclusion. 3. Incapacity/Inability to attend the follow-up visits. 4. Patient refusing to participate in the study. 5. HIV positive patients. 6. Incapacity to understand the study objective and process, to agree or to give informed consent to participate in the study. 7. Pregnant or breast-feeding women
| Facility | City | Country | Status |
|---|---|---|---|
| CH William Morey Chalon-sur-Saône | Chalon-sur-Saône | France | |
| CHD Vendée | La Roche-sur-Yon | France | |
| CH la Rochelle - Hôpital Saint Louis | La Rochelle | France | |
| CH Orléans | Orléans | France | |
| CHU Bordeaux Centre François Magendie Hopital Haut -Lévêque | Pessac | France | |
| CH Saint Malo | St-Malo | France |