Brief Title
Acquired Hemophilia A and Autoimmunity. Study of Lymphocyte Populations and Myeloid-Derived Suppressor Cells
Official Title
Acquired Hemophilia A and Autoimmunity. Study of Lymphocyte Populations and Myeloid-Derived Suppressor Cells
Brief Summary
Acquired hemophilia A is a rare condition of hemostasis secondary to the development of
antibodies against factor VIII. This is a potentially serious pathology that can be
life-threatening due to the major risk of bleeding caused by the sometimes drastic decrease
in the level of circulating factor VIII.
This pathology occurs overwhelmingly in elderly subjects or, more rarely, in young women,
during the postpartum period. It appears idiopathic in 50% of cases and associated, for the
other cases, with underlying pathologies such as autoimmune pathologies (rheumatoid arthritis
and bullous pemphigoid in particular) and neoplasias, or with a particular circumstance
represented by the post -partum.
The association between this autoimmune pathology and its association with pathologies of the
same type or with circumstances involving the immune system, suggests that common mechanisms
could favor its emergence.
This study therefore proposes to study lymphocyte populations and subpopulations as well as
Myeloid-Derived Suppressor Cells and the cytokine profile, which are abnormal in a large part
of autoimmune pathologies.
Study Type
Observational
Primary Outcome
Evaluate the evolution of lymphocyte populations and subpopulations, MDSCs and inflammatory cytokines in patients with hemophilia A acquired at diagnosis and during follow-up
Secondary Outcome
To test the link between the severity of the disease at diagnosis and the cellular and cytokine parameters.
Condition
Hemophilia A
Intervention
no intervention
Study Arms / Comparison Groups
Patients in the Acquired Hemophilia A group.
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
40
Start Date
November 30, 2021
Completion Date
April 1, 2023
Primary Completion Date
April 1, 2023
Eligibility Criteria
Inclusion Criteria:
1. Patient population with acquired hemophilia A:
Adult patients with a diagnosis of acquired hemophilia A and with a social security
system. Obtaining oral non-opposition from the patient to participate in the study
following the submission of an information note relating to the project.
Obtaining signed and written informed consent for biocollection consent.
2. Population of Patients with constitutional hemophilia A:
Adult patients over 50 years of age with severe or moderate constitutional hemophilia
A, with no history of autoimmune disease, and with a social security system.
Obtaining oral non-opposition from the patient to participate in the study following
the submission of an information note relating to the project.
Obtaining signed and written informed consent for biocollection consent.
3. Population of control subjects:
Adult patients, over the age of 60, without a coagulation abnormality, with no history
of autoimmune disease, and with a social security system.
Obtaining oral non-opposition from the patient to participate in the study following
the submission of an information note relating to the project.
Obtaining signed and written informed consent for biocollection consent.
4. Patient population with inflammatory pathology:
Adult patients over the age of 50 with an inflammatory pathology likely to be associated
with acquired hemophilia A, and with a social security system.
Obtaining oral non-opposition from the patient to participate in the study following the
submission of an information note relating to the project.
Obtaining signed and written informed consent for biocollection consent.
Exclusion Criteria:
For the 4 groups:
- Minor patient, under guardianship or curatorship.
- Pregnant and lactating women.
- Blood transfusion less than 7 days old.
- Treatment with corticosteroids in the 7 days preceding inclusion or any other
immunomodulatory or immunosuppressive treatment in the 4 weeks preceding inclusion.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
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Location Countries
France
Location Countries
France
Administrative Informations
NCT ID
NCT04805021
Organization ID
RC20_0253
Responsible Party
Sponsor
Study Sponsor
Nantes University Hospital
Study Sponsor
, ,
Verification Date
January 2022