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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 October 2022 |
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Main ID: |
NCT02158195 |
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Date of registration:
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05/03/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Immunopathology of Autoimmune Hemolytic Anemia
IAHAI |
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Scientific title:
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Immunopathology of Autoimmune Hemolytic Anemia: an Open, Prospective and Multicenter Study |
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Date of first enrolment:
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July 3, 2013 |
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Target sample size:
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27 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02158195 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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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
Age minimum:
16 Years
Age maximum:
N/A
Gender:
All
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Health Condition(s) or Problem(s) studied
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Autoimmune Hemolytic Anemia
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Intervention(s)
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Biological: blood samples
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Primary Outcome(s)
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physiological parameter : blood level of regulatory T cells (Treg, CD4+CD25HighFoxp3+)
[Time Frame: Change from baseline to 3 months]
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physiological parameter : percentage of inhibiting LT proliferation inhibition
[Time Frame: Change from baseline to 3 months]
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Secondary ID(s)
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AUDIA APJ 2012
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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