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

Octapharma

Status: Completed

Conditions: Secondary Immune Deficiency

Treatments: Drug: Gammanorm; Drug: Other Subcutaneous Immunoglobulins

Study type: Observational

Funder types: Industry

Identifiers

NCT03369301

Optinorm

Details and patient eligibility

About

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.

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

102 participants in 2 patient groups

Gammanorm

Description:

Patients on Gammanorm per standard of care

Treatment:

Drug: Gammanorm

Other Subcutaneous Immunoglobulin

Description:

Patients on subcutaneous immunoglobulin treatments other than Gammanorm

Treatment:

Drug: Other Subcutaneous Immunoglobulins