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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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28 June 2021 |
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Main ID: |
NCT02828670 |
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Date of registration:
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23/06/2016 |
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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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Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA)
TFH and AIHA |
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Scientific title:
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Role of T Follicular Helper Cells in Autoimmune Hemolytic Anemia (TFH in AIHA) |
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Date of first enrolment:
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June 7, 2016 |
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Target sample size:
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50 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02828670 |
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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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Contacts
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Name:
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Sylvain AUDIA |
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Address:
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Telephone:
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3.80.29.34.32 |
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Email:
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sylvain.audia@chu-dijon.fr |
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Affiliation:
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Name:
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Sylvain AUDIA |
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Address:
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Telephone:
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3.80.29.34.32 |
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Email:
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sylvain.audia@chu-dijon.fr |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Patients with a diagnosis of warm AIHA defined by
- Hemoglobin <11 g/dl
- Low haptoglobin level
- Positive direct antiglobulin test (IgG or IgG + complement)
- Reticulocyte count >120 G/L
- Patients
- naive to treatment for hemolytic anemia or a in relapse
- Older than 18 years
- Able to understand written and spoken French
- Persons who have provided written consent
Control population
- Patients who have given consent
- Patients over 18 years
- Patients with cold agglutinin disease (progressive AIHA and different treatments of
warm autoantibody AIHA) can be included as a sub-group of controls
- Patients with non-auto-immune hemolytic anemia (constitutional of enzymatic origin,
membrane-related,…) can be included as a sub-group of controls
Exclusion Criteria:
- Patients without national health insurance
- Pregnancy or breast-feeding women
- Adults under guardianship
- Patients with cancer or malignant hemopathy
- Patients with an on-going infection
- Patients treated with corticoids or immunosuppressants
Age minimum:
18 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 sample
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Procedure: spleen sample
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Primary Outcome(s)
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the proportion of circulating T follicular helper lymphocytes (TFH) in patients with Autoimmune Hemolytic Anemia (AIHA) and in control subjects.
[Time Frame: baseline]
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the proportion of circulating TFH in patients with Autoimmune Hemolytic Anemia (AIHA), at diagnosis and after 3 months of treatment with steroids
[Time Frame: through study completion, an average of 1 year]
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Secondary ID(s)
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AUDIA APJ 2014
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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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