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

NCT ID: NCT04805021

Last Updated: 2024-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-11-30

Study Completion Date

2025-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Hemophilia A

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients in the Acquired Hemophilia A group.

no intervention

Intervention Type OTHER

no intervention

patients in the constitutional hemophilia A group.

no intervention

Intervention Type OTHER

no intervention

patients in the control subjects group.

no intervention

Intervention Type OTHER

no intervention

patients in the group of patients with inflammatory pathology.

no intervention

Intervention Type OTHER

no intervention

Interventions

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no intervention

no intervention

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Nantes University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Marc Fouassier

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

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CHU de Nantes

Nantes, , France

Site Status RECRUITING

CH de Saint Nazaire

Saint-Nazaire, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Marc Fouassier

Role: CONTACT

02 40 08 40 49

Facility Contacts

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Marc Fouassier

Role: primary

02 40 08 40 49

Julie Graveleau

Role: primary

0000000000

Other Identifiers

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RC20_0253

Identifier Type: -

Identifier Source: org_study_id

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