Immunopathology of Autoimmune Hemolytic Anemia (IAHAI)

September 19, 2022 updated by: Centre Hospitalier Universitaire Dijon

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

27

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Besançon, France, 25030
        • CHU de Besancon
      • Chalon-sur-Saône, France, 71100
        • CH de Chalon-sur-Saône
      • Dijon, France, 21079
        • CHU de Dijon
      • Metz, France, 57000
        • CH de METZ
      • Mâcon, France, 71018
        • CH de Macon

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with warm primary or secondary Autoimmune Hemolytic Anemia

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre Hospitalier Universitaire Dijon

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2013

Primary Completion (Actual)

December 27, 2018

Study Completion (Actual)

December 27, 2018

Study Registration Dates

First Submitted

March 5, 2014

First Submitted That Met QC Criteria

June 5, 2014

First Posted (Estimate)

June 6, 2014

Study Record Updates

Last Update Posted (Actual)

September 21, 2022

Last Update Submitted That Met QC Criteria

September 19, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AUDIA APJ 2012

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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