An observational study in Secondary Immune Deficiency, sponsored by Octapharma. Completed at 6 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-03-02.
Sponsored by Octapharma · Observational
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.
Every eligible patient for the selection criteria will be consecutively included in the study to avoid any selection bias.
Exclusion Criteria:
Patients on Gammanorm per standard of care
Drug: Gammanorm
Patients on subcutaneous immunoglobulin treatments other than Gammanorm
Drug: Other Subcutaneous Immunoglobulins
Gammanorm given per standard of care
Other Subcutaneous Immunoglobulins given per standard of care
Distribution of difference subclasses of IgGs with respect to subcutaneous immunoglobulin treatment
Distribution of difference subclasses of IgGs with respect to subcutaneous immunoglobulin treatment collected as biological data including immunoglobulins (quantitative dosage and electrophoresis), lymphocytes, CD14 monocytes, polynuclear neutrophils, polynuclear basophils and dendritic cells
Time frame: 12 months
Change in immune system
To analyze the change in the immune system (CD14 monocytes, polynuclear neutrophils, polynuclear basophils and dendritic cells)
Time frame: 12 months
IgG levels
To analyze the IgG levels with respect to the IgSC treatment
Time frame: 12 months
Lymphocytic Repertoire analyzing the evolution of the lymphocytic repertoire (CD3, CD4, CD8, CD19, CD56, and CD27).
To analyze the evolution of the lymphocytic repertoire (CD3, CD4, CD8, CD19, CD56, and CD27).
Time frame: 12 months
IgSC treatment
To characterize the IgSC treatment duration and the patient management (observance, duration and reason of termination)
Time frame: 12 months
Bacterial Infections
To evaluate the severe and non-severe bacterial infection rates
Time frame: 12 months
Antibiotic Consumption
To evaluate the antibiotics consumption during the study
Time frame: 12 months
Hospitalizations due to infections
Evaluate the hospitalization rates due to infections
Time frame: 12 months
Safety of IgSCs to characterize the IgSCs safety, including the adverse events that are not considered to be related to the study treatment
To characterize the IgSCs safety, including the adverse events that are not considered to be related to the study treatment
Time frame: 12 months
Predictive Factors of Recurrent Infections
To characterize potential predictive factors or markers of recurrent infections despite of the Ig treatment by collecting information about infections at follow up visits, especially bacterial infections and their respective antibiotherapy
Time frame: 12 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.
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