Immunopathology of Autoimmune Hemolytic Anemia

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

Sponsors

Lead Sponsor: Centre Hospitalier Universitaire Dijon

Source 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.

Overall Status Unknown status
Start Date July 2013
Completion Date July 2018
Primary Completion Date July 2018
Study Type Observational
Primary Outcome
Measure Time Frame
physiological parameter : blood level of regulatory T cells (Treg, CD4+CD25HighFoxp3+) Change from baseline to 3 months
physiological parameter : percentage of inhibiting LT proliferation inhibition Change from baseline to 3 months
Enrollment 24
Condition
Intervention

Intervention Type: Biological

Intervention Name: blood samples

Eligibility

Sampling Method: Probability Sample

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

Gender: All

Minimum Age: 16 Years

Maximum Age: N/A

Healthy Volunteers: Accepts Healthy Volunteers

Overall Contact

Last Name: Sylvain AUDIA

Phone: 3.80.29.34.32

Phone Ext.: +33

Email: [email protected]

Location
Facility: Status: Contact:
CHU de Besançon | Besançon, 25030, France Not yet recruiting Eric DECONINCK
CH de Chalon-sur-Saône | Chalon-sur-Saône, 71100, France Recruiting Bruno SALLES
CHU de DIJON | Dijon, 21079, France Recruiting Sylvain AUDIA 3.80.29.34.32 +33 [email protected]
CH de METZ | Metz, 57000, France Recruiting François MAURIER 3 87 39 47 72 +33
CH de Mâcon | Mâcon, 71018, France Recruiting Géraldine RAICHON PATRU
Location Countries

France

Verification Date

March 2018

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Patients

Label: controls

Acronym IAHAI
Study Design Info

Observational Model: Case-Control

Time Perspective: Prospective

Source: ClinicalTrials.gov