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

• Sponsor: Centre Hospitalier Universitaire Dijon (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT02828670
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 83.8
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Hemolytic Anemia	Biological: blood sample; Procedure: spleen sample

Study Design

• Study Type: Observational
• Anticipated Enrollment: 50 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)
• Actual Study Start Date: Jun 7, 2016
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Jun 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
patient	Biological: blood sample; Procedure: spleen sample
control	Biological: blood sample; Procedure: spleen sample

Outcome Measures

Primary Outcome Measures

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

2. 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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Dijon Bourgogne	Dijon		France	21079

Sponsors and Collaborators

• Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT02828670
• Other Study ID Numbers: AUDIA APJ 2014
• First Posted: Jul 11, 2016
• Last Update Posted: Jun 21, 2021
• Last Verified: Jun 1, 2020

• Additional relevant MeSH terms: Anemia; Anemia, Hemolytic; Anemia, Hemolytic, Autoimmune; Hemolysis

Study Results

No Results Posted as of Jun 21, 2021