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Secondary Immune Deficiency

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

Sponsored by Octapharma

About this trial

Last updated 3 years ago

Study ID

Optinorm

Status

Completed

Type

Observational

Placebo

No

Accepting

18-75 Years
18+ Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Ended 6 years ago

What is this trial 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.

What are the participation requirements?

Yes

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.

No

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

Locations

Location

Status