Immunopathology of Autoimmune Hemolytic Anemia

Completed

• Conditions: Autoimmune Hemolytic Anemia
• Interventions: Biological: blood samples

• Registration Number: NCT02158195
• Lead Sponsor: Centre Hospitalier Universitaire Dijon

Brief Summary

Autoimmune hemolytic anemia (AIHA) is an auto-immune disease mediated by specific antibodies targeting red blood cells. Its pathogenesis is not completely understood, and the role of T cells have been rarely studied.

The aim of this study is to compare the frequency of circulating T cells, T cell polarization and functions, notably regulatory T cells, during warm AIHA by comparison to healthy controls.

The role of treatments, such as steroids, will also be determined in patients with warm AIHA.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07-03
• Study First Submitted: 2014-03-05
• Study First Submitted QC: 2014-06-05
• Study First Posted: 2014-06-06
• Primary Completion: 2018-12-27
• Study Completion: 2018-12-27
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-19
• Last Update Posted: 2022-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

• Patients diagnosed with primary warm Autoimmune Hemolytic Anemia (wAIHA)
• Secondary AHAI (infections, hematological diseases, systemic diseases)
• Naive of treatment for hemolytic anemia or in relapse
• Older than 16
• Able to understand written and spoken French
• who have provided written informed consent
• INCLUSION CRITERIA for CONTROLS
• Persons without auto-immune disease, cancer or active infection.
• Older than 16
• Able to understand written and spoken French
• who have provided written informed consent

Exclusion Criteria

• Cold agglutinin disease
• Pregnancy
• Persons without national health insurance

Exclusion Criteria for Controls:

• Subjects treated with corticosteroids or immunosuppressants
• Pregnancy
• Persons without national health insurance

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients	blood samples	-
controls	blood samples	-

Primary Outcome Measures

Name	Time	Method
physiological parameter : percentage of inhibiting LT proliferation inhibition	Change from baseline to 3 months
physiological parameter : blood level of regulatory T cells (Treg, CD4+CD25HighFoxp3+)	Change from baseline to 3 months

Trial Locations

Locations (5)

CHU de Besançon; 🇫🇷 Besançon, France

CH de Chalon-sur-Saône; 🇫🇷 Chalon-sur-Saône, France

CH de METZ; 🇫🇷 Metz, France

CHU de DIJON; 🇫🇷 Dijon, France

CH de Mâcon; 🇫🇷 Mâcon, France