Autoimmune Hemolytic AnemiaIAHAINCT02158195
Immunopathology of Autoimmune Hemolytic Anemia
An observational study of Autoimmune Hemolytic Anemia, run by Centre Hospitalier Universitaire Dijon at 5 sites in France.
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. Read more about this study
- Who is it for?
- Ages 16 years and olderHealthy volunteers can take part
- Conditions the study is for
- Autoimmune Hemolytic Anemia
- What is being tested?
- blood samples
- How many people
- 27 participants
- Where
- 5 sitesFrance
- Study dates
- 3 Jul 2013to 27 Dec 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients diagnosed with warm primary or secondary Autoimmune Hemolytic Anemia
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- Cold agglutinin disease
- Pregnancy
- Persons without national health insurance
- Subjects treated with corticosteroids or immunosuppressants
- Pregnancy
- Persons without national health insurance
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
CHU de Besançon
Besançon, 25030
CH de Chalon-sur-Saône
Chalon-sur-Saône, 71100
CHU de DIJON
Dijon, 21079
CH de Mâcon
Mâcon, 71018
CH de METZ
Metz, 57000
About this study
Official title: 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.
- Conditions
- Autoimmune Hemolytic Anemia
- Being tested
- blood samples
- Medical subject headings
- Anemia, Hemolytic, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesBiological
| Study group | Role | What they receive |
|---|---|---|
| Patients | Not described Receives: Biological: blood samples | |
| controls | Not described Receives: Biological: blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
physiological parameter : blood level of regulatory T cells (Treg, CD4+CD25HighFoxp3+)
Measured: Change from baseline to 3 months
physiological parameter : percentage of inhibiting LT proliferation inhibition
Measured: Change from baseline to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2014 (estimated)
- Study start3 Jul 2013
- Primary completion27 Dec 2018
- Study completion27 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Autoimmune Hemolytic AnemiaStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02158195
- Sponsor's protocol ID
- AUDIA APJ 2012
- Acronym
- IAHAI
- Status last verified
- Feb 2026
- First submitted
- 5 Mar 2014
- Last updated
- 9 Feb 2026
- Results posted
- No
Publications
Ciudad M, Ouandji S, Lamarthee B, Cladiere C, Ghesquiere T, Nivet M, Thebault M, Boidot R, Soudry-Faure A, Chevrier S, Richard C, Maillet T, Maurier F, Greigert H, Genet C, Ramon A, Trad M, Predan V, Saas P, Samson M, Bonnotte B, Audia S. Regulatory T-cell dysfunctions are associated with increase in tumor necrosis factor alpha in autoimmune hemolytic anemia and participate in Th17 polarization. Haematologica. 2024 Feb 1;109(2):444-457. doi: 10.3324/haematol.2023.282859.
PubMed 37534543Audia S, Bach B, Samson M, Lakomy D, Bour JB, Burlet B, Guy J, Duvillard L, Branger M, Leguy-Seguin V, Berthier S, Michel M, Bonnotte B. Venous thromboembolic events during warm autoimmune hemolytic anemia. PLoS One. 2018 Nov 8;13(11):e0207218. doi: 10.1371/journal.pone.0207218. eCollection 2018.
PubMed 30408135
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunopathology of Autoimmune Hemolytic Anemia: an Open, Prospective and Multicenter Study
- ClinicalTrials.gov ID
- NCT02158195
- Acronym / sponsor ID
- IAHAI / AUDIA APJ 2012
- Conditions
- Autoimmune Hemolytic Anemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 3 Jul 2013 (actual)
- Primary completion
- 27 Dec 2018 (actual)
- Study completion
- 27 Dec 2018 (actual)
- First posted
- 6 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Biological: blood samples |
| controls | – | Biological: blood samples |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients diagnosed with warm primary or secondary Autoimmune Hemolytic Anemia
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- Cold agglutinin disease
- Pregnancy
- Persons without national health insurance
- Subjects treated with corticosteroids or immunosuppressants
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| blood samples | Biological | Patients, controls |
Primary outcome
physiological parameter : blood level of regulatory T cells (Treg, CD4+CD25HighFoxp3+)
Time frame: Change from baseline to 3 months
physiological parameter : percentage of inhibiting LT proliferation inhibition
Time frame: Change from baseline to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publication: PubMed 37534543Ciudad M, Ouandji S, Lamarthee B, Cladiere C, Ghesquiere T, Nivet M, Thebault M, Boidot R, Soudry-Faure A, Chevrier S, Richard C, Maillet T, Maurier F, Greigert H, Genet C, Ramon A, Trad M, Predan V, Saas P, Samson M, Bonnotte B, Audia S. Regulatory T-cell dysfunctions are associated with increase in tumor necrosis factor alpha in autoimmune hemolytic anemia and participate in Th17 polarization. Haematologica. 2024 Feb 1;109(2):444-457. doi: 10.3324/haematol.2023.282859.
- Derived from this study: PubMed 30408135Audia S, Bach B, Samson M, Lakomy D, Bour JB, Burlet B, Guy J, Duvillard L, Branger M, Leguy-Seguin V, Berthier S, Michel M, Bonnotte B. Venous thromboembolic events during warm autoimmune hemolytic anemia. PLoS One. 2018 Nov 8;13(11):e0207218. doi: 10.1371/journal.pone.0207218. eCollection 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Autoimmune Hemolytic Anemia, run by Centre Hospitalier Universitaire Dijon at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
physiological parameter : blood level of regulatory T cells (Treg, CD4+CD25HighFoxp3+) (time frame: Change from baseline to 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02158195, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Feb 2026.