Immunoglobulin Efficacy and Immune Profiling in Antibody Immunodeficiency (NCT07516002) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Immunoglobulin Efficacy and Immune Profiling in Antibody Immunodeficiency
15 participantsStarted 2026-04-01
Plain-language summary
This study aims to systematically evaluate the dynamic alterations in peripheral immune subsets among patients with antibody Immunodeficiency undergoing Immunoglobulin therapy
Who can participate
Age range5 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:Confirmed Diagnosis: Diagnosis of primary antibody immunodeficiency based on clinical presentation and laboratory evidence of impaired antibody production. Diagnoses should align with standard criteria (e.g., ESID/IUIS diagnostic criteria).
Laboratory Evidence: Documented quantitative deficiency in serum immunoglobulins, defined as reduced IgG, IgA, and/or IgM levels below the age-adjusted lower limit of normal, and/or demonstrated poor specific antibody response to vaccines.
Age: Patients aged between 5 and 50 years (inclusive) at the time of screening. Treatment Status: Currently receiving or scheduled to initiate regular immunoglobulin replacement therapy.
Consent: Provision of written informed consent by the patient or their legal guardian, along with documented assent from pediatric participants where developmentally appropriate.
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Exclusion Criteria:Secondary Immunodeficiency: Presence of other severe comorbidities that may affect immune function. This specifically includes secondary causes of hypogammaglobulinemia, such as active malignancies, protein-losing enteropathy, nephrotic syndrome, or untreated HIV infection.
Other PIDs: Confirmed diagnosis of primary immunodeficiency disorders other than predominantly antibody deficiency.
Confounding Medications: Use of systemic immunosuppressive or targeted immunomodulatory drugs within 3 months prior to enrollment. Patients on stable immunoglobulin replacement therapy are exempt from this exclusio…
What they're measuring
1
Change in Peripheral Blood T-cell and B-cell Subsets
Timeframe: Baseline (Month 0), Month 6, and Month 12.
2
Annualized Infection Rate (AIR)
Timeframe: Prospectively assessed from Baseline up to Month 12.