Effect of Subcutaneous Immunoglobulin (IgSC) Gammanorm® on the Distribution of IgG Subclasses and on the Humoral Immunity of Patients With Secondary Immunodeficiency.
Data Collection
Collected from today forward - ProspectiveCase-Only
Examining characteristics of individuals with a disease in order to identify genetic or environmental factors contributing to the condition.Summary
Study start date: September 25, 2017
Actual date on which the first participant was enrolled.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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.102 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Case-only
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.Over 18 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.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
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 6 locations
CH William Morey Chalon-sur-Saône
Chalon-sur-Saône, FranceOpen CH William Morey Chalon-sur-Saône in Google MapsCHD Vendée
La Roche-sur-Yon, FranceCH la Rochelle - Hôpital Saint Louis
La Rochelle, FranceCH Orléans
Orléans, France