IAHAI: Immunopathology of Autoimmune Hemolytic Anemia

• Sponsor: Centre Hospitalier Universitaire Dijon (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02158195
• Collaborator: (none)
• Enrollment: 24
• Locations: 5
• Duration (Months): 60
• Patients Per Site: 4.8
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Autoimmune Hemolytic Anemia	Biological: blood samples

Study Design

• Study Type: Observational
• Anticipated Enrollment: 24 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• Official Title: Immunopathology of Autoimmune Hemolytic Anemia: an Open, Prospective and Multicenter Study
• Study Start Date: Jul 1, 2013
• Anticipated Primary Completion Date: Jul 1, 2018
• Anticipated Study Completion Date: Jul 1, 2018

Arms and Interventions

Arm	Intervention/Treatment
Patients	Biological: blood samples
controls	Biological: blood samples

Outcome Measures

Primary Outcome Measures

1. physiological parameter : blood level of regulatory T cells (Treg, CD4+CD25HighFoxp3+) [Change from baseline to 3 months]

2. physiological parameter : percentage of inhibiting LT proliferation inhibition [Change from baseline to 3 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 16 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU de Besançon	Besançon		France	25030
2	CH de Chalon-sur-Saône	Chalon-sur-Saône		France	71100
3	CHU de DIJON	Dijon		France	21079
4	CH de METZ	Metz		France	57000
5	CH de Mâcon	Mâcon		France	71018

Sponsors and Collaborators

• Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Centre Hospitalier Universitaire Dijon
• ClinicalTrials.gov Identifier: NCT02158195
• Other Study ID Numbers: AUDIA APJ 2012
• First Posted: Jun 6, 2014
• Last Update Posted: Mar 15, 2018
• Last Verified: Mar 1, 2018

• Additional relevant MeSH terms: Anemia; Anemia, Hemolytic; Anemia, Hemolytic, Autoimmune; Hemolysis

Study Results

No Results Posted as of Mar 15, 2018