IEIPAI
Real-world Efficacy of Immunoglobulin in Antibody Immunodeficiency: A Prospective Cohort Study Based on T/B Cell Subset Profiling
Sponsor study identifier
observational
15
0 countries
N/A
Study Start
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
This study aims to systematically evaluate the dynamic alterations in peripheral immune subsets among patients with antibody Immunodeficiency undergoing Immunoglobulin therapy
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 31, 2026
Actual (reported)April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
April 7, 2026
Actual (reported)October 1, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Change in Peripheral Blood T-cell and B-cell Subsets
Quantification of the absolute counts and percentages of specific lymphocyte subsets to evaluate the T-B cell interaction. B-cell subsets include switched memory B cells, non-switched memory B cells, plasmablasts, and double-negative (DN) B cells. T-cell subsets include circulating follicular helper T cells (pTfh), CD4+ T cells, CD8+ T cells, and regulatory T cells (Tregs). Measurements will be performed using high-resolution multiparametric flow cytometry.
Baseline (Month 0), Month 6, and Month 12.
Annualized Infection Rate (AIR)
The primary clinical efficacy outcome is the incidence of breakthrough infections. This is defined as the number of severe or moderate infection episodes per patient per year requiring hospitalization, intravenous antibiotics, or prolonged oral antibiotics (\>7 days).
Prospectively assessed from Baseline up to Month 12.
Correlation Between Immune Phenotypes and IgG Trough Levels
Baseline (Month 0), Month 6, and Month 12.
Incidence and Evolution of Autoimmune Manifestations
Prospectively assessed from Baseline up to Month 12.
Prospective cohort of patients with antibody immunodeficiency, receiving standard immunoglobulin replacement therapy. Immune profiling (T/B cell subsets) will be performed to evaluate real-world efficacy and immune reconstitution.
Patients with primary antibody immunodeficiency, aged 18 years and older, who are receiving regular immunoglobulin replacement therapy at the study site. Exclusion criteria include active infection, recent immunosuppressive treatment, or prior hematopoietic stem cell transplantation.
Zhanguo Li
Study Principal Investigator Peking University Institute of Rheuamotology and Immunology
First Submitted
March 31, 2026
First Posted
April 7, 2026
Study Start
April 1, 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
October 1, 2029
Virtual Reality on Pain and Fear Levels of Children With Primary Immunodeficiency
Primitive Immunodeficiency, Intrauterine Devices and Menstrual Hygiene Products
Contact the study team to confirm eligibility.
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 30, 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 7, 2026
Record last verified: 2026-03
De-identified individual participant data (IPD) that underlie the results reported in this article will be shared. Data will be available beginning 6 months and ending 36 months following article publication, to researchers who provide a methodologically sound proposal approved by an independent review committee, for the purpose of achieving the aims in the approved proposal. Proposals should be directed to the corresponding author.
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Source: ClinicalTrials.gov.
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