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NCT02158195 Clinical Trial

Immunopathology of Autoimmune Hemolytic Anemia

Autoimmune Hemolytic Anemia Clinical Trial

— IAHAI  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02158195
Other study ID # AUDIA APJ 2012
Secondary ID
Status Completed
Phase
First received
Last updated
Start date July 3, 2013
Est. completion date December 27, 2018

Study information
Verified date September 2022
Source Centre Hospitalier Universitaire Dijon
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 27
Est. completion date December 27, 2018
Est. primary completion date December 27, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Biological:
• blood samples

Locations
Country Name City State
France CHU de Besançon Besançon
France CH de Chalon-sur-Saône Chalon-sur-Saône
France CHU de DIJON Dijon
France CH de Mâcon Mâcon
France CH de METZ Metz

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 physiological parameter : blood level of regulatory T cells (Treg, CD4+CD25HighFoxp3+) Change from baseline to 3 months
Primary physiological parameter : percentage of inhibiting LT proliferation inhibition Change from baseline to 3 months
See also
  Status Clinical Trial Phase
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Recruiting NCT05937828 - OBS'CEREVANCE: French Cohort of Pediatric Autoimmune Cytopenia
Recruiting NCT05263817 - A Clinical Study of CD19/BCMA CAR-T Cells in the Treatment of Refractory POEMS Syndrome, Amyloidosis, Autoimmune Hemolytic Anemia, and Vasculitis Early Phase 1
Completed NCT03269292 - Clinical Characteristics and Treatment Outcomes of Patients With Autoimmune Hemolytic Anemia
Recruiting NCT05694312 - Ibrutinib for the Treatment of AIHA in Patients With CLL/SLL or CLL-like MBL Phase 2
Completed NCT03538041 - A Study of INCB050465 in Participants With Autoimmune Hemolytic Anemia Phase 2
Recruiting NCT03918265 - Tacrolimus Treatment for Refractory Autoimmune Cytopenia Phase 4
Completed NCT02389231 - Evaluating the Interest of Interleukine-2 for Patients With Active Warm Hemolytic Anemia Resistant to Conventional Treatment Phase 1/Phase 2
Active, not recruiting NCT03576742 - Severe Immune Cytopenia Registry Www.Sic-reg.Org
Active, not recruiting NCT04657094 - Acalabrutinib for the Treatment of Relapsed or Refractory Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia Phase 2
Recruiting NCT02828670 - Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)
Recruiting NCT02877706 - French Registry of Adult Patients With Immune Thrombocytopenia and Autoimmune Hemolytic Anemia
Recruiting NCT05931718 - Prospective Evaluation of Diagnosis and Treatment of Patients With Autoimmune Cytopenias Including Autoimmune Hemolytic Anemia, Immune Thrombocytopenia, and Chronic Idiopathic/Autoimmune Neutropenia
Completed NCT00001630 - Treatment of Autoimmune Thrombocytopenia (AITP) Phase 1
Withdrawn NCT04039477 - A Phase 2 Study to Evaluate the Safety and Efficacy of KZR-616 in Patients With AIHA and ITP Phase 2
Recruiting NCT04024202 - Data Registry of Auto Immune Hemolytic Anemia
Not yet recruiting NCT05711264 - Presence of Circulating Cluster of Differentiation 4 Positive 28 Null T Helper Lymphocytes(CD4+CD28-) in Patients With Autoimmune Hemolytic Anemia.
Completed NCT02689986 - Bendamustine and Rituximab Combination Therapy for Cold Agglutinin Disease Phase 2
Recruiting NCT06212154 - CAR-T for Autoimmune Hemolytic Anemia Patients Who Have Failed Three or More Lines of Therapy Phase 1
Completed NCT04057703 - Balance Benefit / Risk of Immunomodulatory Treatments at the Child and Adolescent for Autoimmune Cytopenia.