Clinical trial NCT03369301: The Effect of Subcutaneous Immunoglobulin Gammanorm on the Distribution of IgG Subclasses and on Immunity of Patients With Secondary Immunodeficiency
Official title: Effect of Subcutaneous Immunoglobulin (IgSC) Gammanorm® on the Distribution of IgG Subclasses and on the Humoral Immunity of Patients With Secondary Immunodeficiency.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Secondary Immune Deficiency
Lead sponsor: Octapharma
Sponsor class: INDUSTRY
First posted: 2017-12-12
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Every eligible patient for the selection criteria will be consecutively included in the study to avoid any selection bias.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Distribution of difference subclasses of IgGs with respect to subcutaneous immunoglobulin treatment
timeFrame: 12 months
Secondary outcomes:
measure: Change in immune system
timeFrame: 12 months
measure: IgG levels
timeFrame: 12 months
measure: Lymphocytic Repertoire analyzing the evolution of the lymphocytic repertoire (CD3, CD4, CD8, CD19, CD56, and CD27).
timeFrame: 12 months
measure: IgSC treatment
timeFrame: 12 months
measure: Bacterial Infections
timeFrame: 12 months
measure: Antibiotic Consumption
timeFrame: 12 months
measure: Hospitalizations due to infections
timeFrame: 12 months
measure: Safety of IgSCs to characterize the IgSCs safety, including the adverse events that are not considered to be related to the study treatment
timeFrame: 12 months
measure: Predictive Factors of Recurrent Infections
timeFrame: 12 months
Other outcomes:
Locations:
city: Chalon-sur-Saône
country: France
facility: CH William Morey Chalon-sur-Saône
city: La Roche-sur-Yon
country: France
facility: CHD Vendée
city: La Rochelle
country: France
facility: CH la Rochelle - Hôpital Saint Louis
city: Orléans
country: France
facility: CH Orléans
city: Pessac
country: France
facility: CHU Bordeaux Centre François Magendie Hopital Haut -Lévêque
city: Saint-Malo
country: France
facility: CH Saint Malo
Study officials:
References: