D83.9
Conditions
Interventions
Group 1: Immunoglobulin replacement therapy (IgGRT) naïve CVID patients which fulfill the diagnostic criteria for CVID requiring IgGRT. Retrospective data and blood samples collected as part of the r
Sponsors
Universitätsklinikum Freiburg
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Diagnosis of CVID according to ESID/PAGID criteria or diagnosis of related disorders which fulfill the diagnostic criteria for CVID. 2. Patients with the need for IgGRT according to standard guidelines. 3. Patients who received an initial intravenous IgG replacement therapy (IVIG) 4. Signed written informed consent
Exclusion criteria
Exclusion criteria: 1. Immunosuppressive therapy beyond 7.5 mg prednisone equivalent/day during the observation period, including biologicals 2. Patients on IgGRT within the last two years before collection of baseline data 3. Lymphoma or other form of malignancy within the past 5 years before collection of baseline data
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defined set of candidate biomarkers, to distinguish the immune response at three months after initiation of IgGRT in infection-only-CVID (CVIDio) patients versus patients with inflammatory and autoimmune complications-CVID (CVIDc) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Identified pathways, cellular and molecular components to distinguish CVIDio vs CVIDc before initiation of IgGRT • Identified pathways, cellular and molecular components to distinguish CVIDio vs CVIDc immediate and six months after initiation of IgGRT • Defined set of biomarkers distinguishing the immune status before, immediately, and six months after initiation of IgGRT in CVIDio vs CVIDc. | — |
Countries
Germany
Contacts
Public ContactKlaus Warnatz
Universitätsklinikum Freiburg
Outcome results
None listed