NCT02158195

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jul 2013

Longer than P75 for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2013

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2014

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 6, 2014

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 27, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2018

Completed
Last Updated

February 9, 2026

Status Verified

February 1, 2026

Enrollment Period

5.5 years

First QC Date

March 5, 2014

Last Update Submit

February 5, 2026

Conditions

Autoimmune Hemolytic Anemia

Outcome Measures

Primary Outcomes (2)

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

    Change from baseline to 3 months

  • physiological parameter : percentage of inhibiting LT proliferation inhibition

    Change from baseline to 3 months

Study Arms (2)

Patients

Biological: blood samples

controls

Biological: blood samples

Interventions

blood samplesBIOLOGICAL
Patientscontrols

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients diagnosed with warm primary or secondary Autoimmune Hemolytic Anemia

You may qualify if:

  • 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
  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU de Besançon

Besançon, 25030, France

Location

CH de Chalon-sur-Saône

Chalon-sur-Saône, 71100, France

Location

CHU de DIJON

Dijon, 21079, France

Location

CH de Mâcon

Mâcon, 71018, France

Location

CH de METZ

Metz, 57000, France

Location

Related Publications (2)

  • Ciudad M, Ouandji S, Lamarthee B, Cladiere C, Ghesquiere T, Nivet M, Thebault M, Boidot R, Soudry-Faure A, Chevrier S, Richard C, Maillet T, Maurier F, Greigert H, Genet C, Ramon A, Trad M, Predan V, Saas P, Samson M, Bonnotte B, Audia S. Regulatory T-cell dysfunctions are associated with increase in tumor necrosis factor alpha in autoimmune hemolytic anemia and participate in Th17 polarization. Haematologica. 2024 Feb 1;109(2):444-457. doi: 10.3324/haematol.2023.282859.

    PMID: 37534543RESULT

  • Audia S, Bach B, Samson M, Lakomy D, Bour JB, Burlet B, Guy J, Duvillard L, Branger M, Leguy-Seguin V, Berthier S, Michel M, Bonnotte B. Venous thromboembolic events during warm autoimmune hemolytic anemia. PLoS One. 2018 Nov 8;13(11):e0207218. doi: 10.1371/journal.pone.0207218. eCollection 2018.

    PMID: 30408135DERIVED

MeSH Terms

Conditions

Anemia, Hemolytic, Autoimmune

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Anemia, HemolyticAnemiaHematologic DiseasesHemic and Lymphatic DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 5, 2014

First Posted

June 6, 2014

Study Start

July 3, 2013

Primary Completion

December 27, 2018

Study Completion

December 27, 2018

Last Updated

February 9, 2026

Record last verified: 2026-02

Locations

FR(5)