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

Secondary Immune Deficiency Clinical Trial

Official title:

Effect of Subcutaneous Immunoglobulin (IgSC) Gammanorm® on the Distribution of IgG Subclasses and on the Humoral Immunity of Patients With Secondary Immunodeficiency.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03369301
• Other study ID #: Optinorm
• Status: Completed
• Start date: September 25, 2017
• Est. completion date: November 22, 2019

Study information

• Verified date: February 2022
• Source: Octapharma
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: November 22, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Immunologic Deficiency Syndromes
• Neoplasm Metastasis
• Secondary Immune Deficiency

Intervention

Drug:
• Gammanorm
Gammanorm given per standard of care
• Other Subcutaneous Immunoglobulins
Other Subcutaneous Immunoglobulins given per standard of care

Locations

Country	Name	City	State
France	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	Saint-Malo

Sponsors (1)

Lead Sponsor	Collaborator
Octapharma

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months
Secondary	Change in immune system	To analyze the change in the immune system (CD14 monocytes, polynuclear neutrophils, polynuclear basophils and dendritic cells)	12 months
Secondary	IgG levels	To analyze the IgG levels with respect to the IgSC treatment	12 months
Secondary	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).	12 months
Secondary	IgSC treatment	To characterize the IgSC treatment duration and the patient management (observance, duration and reason of termination)	12 months
Secondary	Bacterial Infections	To evaluate the severe and non-severe bacterial infection rates	12 months
Secondary	Antibiotic Consumption	To evaluate the antibiotics consumption during the study	12 months
Secondary	Hospitalizations due to infections	Evaluate the hospitalization rates due to infections	12 months
Secondary	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	12 months
Secondary	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	12 months