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Immunopathology of Autoimmune Hemolytic Anemia (IAHAI)

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ClinicalTrials.gov Identifier: NCT02158195
Recruitment Status : Recruiting
First Posted : June 6, 2014
Last Update Posted : March 15, 2018
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Autoimmune Hemolytic Anemia Biological: blood samples

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Study Type : Observational
Estimated Enrollment : 24 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Immunopathology of Autoimmune Hemolytic Anemia: an Open, Prospective and Multicenter Study
Study Start Date : July 2013
Estimated Primary Completion Date : July 2018
Estimated Study Completion Date : July 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia

Group/Cohort Intervention/treatment
Patients Biological: blood samples
controls Biological: blood samples



Primary Outcome Measures :
  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 ]


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients diagnosed with warm primary or secondary Autoimmune Hemolytic Anemia
Criteria

Inclusion Criteria:

  • Patients diagnosed with primary warm Autoimmune Hemolytic Anemia (wAIHA)
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02158195


Contacts
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Contact: Sylvain AUDIA 3.80.29.34.32 ext +33 sylvain.audia@chu-dijon.fr

Locations
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France
CHU de Besançon Not yet recruiting
Besançon, France, 25030
Contact: Eric DECONINCK         
CH de Chalon-sur-Saône Recruiting
Chalon-sur-Saône, France, 71100
Contact: Bruno SALLES         
CHU de DIJON Recruiting
Dijon, France, 21079
Contact: Sylvain AUDIA    3.80.29.34.32 ext +33    sylvain.audia@chu-dijon.fr   
CH de METZ Recruiting
Metz, France, 57000
Contact: François MAURIER    3 87 39 47 72 ext +33      
CH de Mâcon Recruiting
Mâcon, France, 71018
Contact: Géraldine RAICHON PATRU         
Sponsors and Collaborators
Centre Hospitalier Universitaire Dijon

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Centre Hospitalier Universitaire Dijon
ClinicalTrials.gov Identifier: NCT02158195     History of Changes
Other Study ID Numbers: AUDIA APJ 2012
First Posted: June 6, 2014    Key Record Dates
Last Update Posted: March 15, 2018
Last Verified: March 2018
Additional relevant MeSH terms:
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Anemia
Anemia, Hemolytic
Anemia, Hemolytic, Autoimmune
Hemolysis
Hematologic Diseases
Pathologic Processes
Autoimmune Diseases
Immune System Diseases