The Effect of Subcutaneous Immunoglobulin Gammanorm on the Distribution of IgG Subclasses and on Immunity of Patients With Secondary Immunodeficiency

Completed

• Conditions: Secondary Immune Deficiency
• Interventions: Drug: Other Subcutaneous Immunoglobulins; Drug: Gammanorm

• Registration Number: NCT03369301
• Lead Sponsor: Octapharma

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-09-25
• Study First Submitted: 2017-11-30
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-12
• Primary Completion: 2019-11-22
• Study Completion: 2019-11-22
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-28
• Last Update Posted: 2022-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Other Subcutaneous Immunoglobulin	Other Subcutaneous Immunoglobulins	Patients on subcutaneous immunoglobulin treatments other than Gammanorm
Gammanorm	Gammanorm	Patients on Gammanorm per standard of care

Primary Outcome Measures

Name	Time	Method
Distribution of difference subclasses of IgGs with respect to subcutaneous immunoglobulin treatment	12 months	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

Secondary Outcome Measures

Name	Time	Method
IgSC treatment	12 months	To characterize the IgSC treatment duration and the patient management (observance, duration and reason of termination)
Predictive Factors of Recurrent Infections	12 months	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
Change in immune system	12 months	To analyze the change in the immune system (CD14 monocytes, polynuclear neutrophils, polynuclear basophils and dendritic cells)
IgG levels	12 months	To analyze the IgG levels with respect to the IgSC treatment
Antibiotic Consumption	12 months	To evaluate the antibiotics consumption during the study
Safety of IgSCs to characterize the IgSCs safety, including the adverse events that are not considered to be related to the study treatment	12 months	To characterize the IgSCs safety, including the adverse events that are not considered to be related to the study treatment
Lymphocytic Repertoire analyzing the evolution of the lymphocytic repertoire (CD3, CD4, CD8, CD19, CD56, and CD27).	12 months	To analyze the evolution of the lymphocytic repertoire (CD3, CD4, CD8, CD19, CD56, and CD27).
Bacterial Infections	12 months	To evaluate the severe and non-severe bacterial infection rates
Hospitalizations due to infections	12 months	Evaluate the hospitalization rates due to infections

Trial Locations

Locations (6)

CH William Morey Chalon-sur-Saône; 🇫🇷 Chalon-sur-Saône, France

CHD Vendée; 🇫🇷 La Roche-sur-Yon, France

CH Orléans; 🇫🇷 Orléans, France

CH Saint Malo; 🇫🇷 Saint-Malo, France

CHU Bordeaux Centre François Magendie Hopital Haut -Lévêque; 🇫🇷 Pessac, France

CH la Rochelle - Hôpital Saint Louis; 🇫🇷 La Rochelle, France