Status:
COMPLETED
The Effect of Subcutaneous Immunoglobulin Gammanorm on the Distribution of IgG Subclasses and on Immunity of Patients With Secondary Immunodeficiency
Lead Sponsor:
Octapharma
Conditions:
Secondary Immune Deficiency
Eligibility:
All Genders
18+ years
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...
Eligibility Criteria
Inclusion
- Adult male or female (≥18 years old), Myeloma or Chronic Lymphocytic Leukemia patients with secondary hypogammaglobinemia and recurring infections.
- 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).
- Patient having received all the necessary information about the study and signed an informed consent document.
Exclusion
- Patient having initiated an IgSC treatment.
- Patient having received IgSC or IgIV treatment within 6 months prior to inclusion.
- Incapacity/Inability to attend the follow-up visits.
- Patient refusing to participate in the study.
- HIV positive patients.
- Incapacity to understand the study objective and process, to agree or to give informed consent to participate in the study.
- Pregnant or breast-feeding women
Key Trial Info
Start Date :
September 25 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 22 2019
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT03369301
Start Date
September 25 2017
End Date
November 22 2019
Last Update
March 2 2022
Active Locations (6)
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1
CH William Morey Chalon-sur-Saône
Chalon-sur-Saône, France, 71100
2
CHD Vendée
La Roche-sur-Yon, France, 85000
3
CH la Rochelle - Hôpital Saint Louis
La Rochelle, France, 17000
4
CH Orléans
Orléans, France, 45100