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

Autoimmune Hemolytic Anemia Clinical Trial

— TFH and AIHA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02828670
• Other study ID #: AUDIA APJ 2014
• Status: Recruiting
• Start date: June 7, 2016
• Est. completion date: June 2023

Study information

• Verified date: June 2020
• Source: Centre Hospitalier Universitaire Dijon
• Contact: Sylvain AUDIA
• Phone: 3.80.29.34.32
• Email: sylvain.audia[@]chu-dijon.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2023
• Est. primary completion date: June 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia, Hemolytic
• Anemia, Hemolytic, Autoimmune
• Autoimmune Hemolytic Anemia
• Hemolysis

Intervention

Biological:
• blood sample

Procedure:
• spleen sample

Locations

Country	Name	City	State
France	CHU Dijon Bourgogne	Dijon

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire Dijon

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the proportion of circulating T follicular helper lymphocytes (TFH) in patients with Autoimmune Hemolytic Anemia (AIHA) and in control subjects.		baseline
Primary	the proportion of circulating TFH in patients with Autoimmune Hemolytic Anemia (AIHA), at diagnosis and after 3 months of treatment with steroids		through study completion, an average of 1 year