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Acquired Hemophilia A and Autoimmunity. Study of Lymphocyte Populations and Myeloid-Derived Suppressor Cells (IMMUNHEMAC)

N

Nantes University Hospital (NUH)

Status

Enrolling

Conditions

Hemophilia A

Treatments

Other: no intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04805021
RC20_0253

Details and patient eligibility

About

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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

40 participants in 4 patient groups

Patients in the Acquired Hemophilia A group.
Treatment:
Other: no intervention
patients in the constitutional hemophilia A group.
Treatment:
Other: no intervention
patients in the control subjects group.
Treatment:
Other: no intervention
patients in the group of patients with inflammatory pathology.
Treatment:
Other: no intervention

Trial contacts and locations

2

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Central trial contact

Marc Fouassier

Data sourced from clinicaltrials.gov

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