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NCT Number: NCT02158195

Immunopathology of Autoimmune Hemolytic Anemia

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.

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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

16 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CHU de Besançon, Besançon, France

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Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

blood samples

Biological

Primary outcomes

  1. physiological parameter : blood level of regulatory T cells (Treg, CD4+CD25HighFoxp3+)

    Time frame: Change from baseline to 3 months

  2. physiological parameter : percentage of inhibiting LT proliferation inhibition

    Time frame: Change from baseline to 3 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Dijon

Other

Registry information

Official study title

Immunopathology of Autoimmune Hemolytic Anemia: an Open, Prospective and Multicenter Study

Acronym: IAHAI

Important dates

Study start
2013
Primary completion
2018
Study completion
2018
First posted
Jun 6, 2014
Registry last updated
Feb 9, 2026

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.

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