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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Autoimmune Hemolytic Anemia Anemia Anemia, Hemolytic Anemia, Hemolytic, Autoimmune Autoimmune Diseases Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU Dijon Bourgogne

Dijon, 21079, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood sample

Biological

spleen sample

Procedure

Primary outcomes

the proportion of circulating T follicular helper lymphocytes (TFH) in patients with Autoimmune Hemolytic Anemia (AIHA) and in control subjects.

Time frame: baseline
the proportion of circulating TFH in patients with Autoimmune Hemolytic Anemia (AIHA), at diagnosis and after 3 months of treatment with steroids

Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Acronym: TFH and AIHA

Important dates

Study start: 2016
Primary completion: 2022
Study completion: 2022
First posted: Jul 11, 2016
Registry last updated: Jul 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed