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Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)

Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02828670
Acronym
TFH and AIHA
Enrollment
25
Registered
2016-07-11
Start date
2016-06-07
Completion date
2022-02-15
Last updated
2024-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Autoimmune Hemolytic Anemia

Brief summary

T follicular helper (TFH) cells represent a T cell subset dedicated to the activation of B cells. They have been involved in the pathogenesis of autoimmune diseases in humans such as lupus and Sjögren disease. We recently showed that TFH are implicated in the activation of autoreactive B lymphocytes during ITP. Autoimmune hemolytic anemia (AIHA) is an autoimmune disease due to antibodies targeting red blood cells. To date, the role of TFH in the pathogenesis of AIHA is not known. We hypothesize that AIHA is associated with an increase in the number and/or function of TFH, that could participate in the activation of autoreactive B lymphocytes.

Interventions

BIOLOGICALblood sample
PROCEDUREspleen sample

Sponsors

Centre Hospitalier Universitaire Dijon
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Patients with a diagnosis of warm AIHA defined by * Hemoglobin \<11 g/dl * Low haptoglobin level * Positive direct antiglobulin test (IgG or IgG + complement) * Reticulocyte count \>120 G/L * Patients * naive to treatment for hemolytic anemia or a in relapse * Older than 18 years * Able to understand written and spoken French * Persons who have provided written consent Control population * Patients who have given consent * Patients over 18 years * Patients with cold agglutinin disease (progressive AIHA and different treatments of warm autoantibody AIHA) can be included as a sub-group of controls * Patients with non-auto-immune hemolytic anemia (constitutional of enzymatic origin, membrane-related,…) can be included as a sub-group of controls

Exclusion criteria

* Patients without national health insurance * Pregnancy or breast-feeding women * Adults under guardianship * Patients with cancer or malignant hemopathy * Patients with an on-going infection * Patients treated with corticoids or immunosuppressants

Design outcomes

Primary

MeasureTime frame
the proportion of circulating T follicular helper lymphocytes (TFH) in patients with Autoimmune Hemolytic Anemia (AIHA) and in control subjects.baseline
the proportion of circulating TFH in patients with Autoimmune Hemolytic Anemia (AIHA), at diagnosis and after 3 months of treatment with steroidsthrough study completion, an average of 1 year

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026