- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04805021
Acquired Hemophilia A and Autoimmunity. Study of Lymphocyte Populations and Myeloid-Derived Suppressor Cells (IMMUNHEMAC)
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 Overview
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Marc Fouassier
- Phone Number: 02 40 08 40 49
- Email: marc.fouassier@chu-nantes.fr
Study Locations
-
-
-
Nantes, France
- Recruiting
- CHU de Nantes
-
Contact:
- Marc Fouassier
- Phone Number: 02 40 08 40 49
- Email: marc.fouassier@chu-nantes.fr
-
Saint-Nazaire, France
- Recruiting
- CH de Saint Nazaire
-
Contact:
- Julie Graveleau
- Phone Number: 0000000000
- Email: j.graveleau@ch-saintnazaire.fr
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Patients with acquired hemophilia A will be recruited prospectively when diagnosed with acquired hemophilia A and will be followed in the study until recovery.
Patients with constitutional hemophilia A will be recruited prospectively. They should be over 50 years old and have severe or moderate hemophilia A, and not be taking any treatment that could interfere with the immune system or inflammatory markers.
Population of control subjects without coagulation abnormalities, over 60 years of age and not taking any treatment likely to interfere with the immune system or inflammatory markers.
Patient population with inflammatory pathology will include subjects with an inflammatory pathology likely, according to the literature, to be associated with acquired hemophilia A and, in particular patients with rheumatoid arthritis, if possible at diagnosis and not taking any treatment likely to interfere with the disease. immune system or inflammatory markers.
Description
Inclusion Criteria:
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.
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.
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.
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Patients in the Acquired Hemophilia A group.
|
no intervention
|
patients in the constitutional hemophilia A group.
|
no intervention
|
patients in the control subjects group.
|
no intervention
|
patients in the group of patients with inflammatory pathology.
|
no intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Evaluate the evolution of lymphocyte populations and subpopulations, MDSCs and inflammatory cytokines in patients with hemophilia A acquired at diagnosis and during follow-up
Time Frame: 2 years
|
Comparisons between diagnosis and during follow-up
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
To test the link between the severity of the disease at diagnosis and the cellular and cytokine parameters.
Time Frame: 2 years
|
Factor VIII level and inhibitor titration at diagnosis
|
2 years
|
Comparisons of baseline lymphocyte and cytokine data between patients with a favorable versus unfavorable final diagnosis.
Time Frame: 2 years
|
Cell populations and cytokine profile and half-life of the inhibitor under treatment, time before normalization of the Factor VIII / Willebrand factor ratio, total duration of treatment with corticosteroids, recurrence and mortality tested to define a favorable course of the disease or unfavorable.
|
2 years
|
Comparison of lymphocyte populations and subpopulations, MDSCs and inflammatory cytokines between different groups.
Time Frame: 2 years
|
Cell populations and cytokine profile of the different groups at diagnosis and at the end of follow-up.
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Marc Fouassier, Nantes University Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RC20_0253
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Hemophilia A
-
Christoph KönigsRoche Pharma AG; Chugai Pharma Germany GmbHRecruitingSevere Hemophilia A | Severe Hemophilia A With Inhibitor | Severe Hemophilia A Without InhibitorGermany
-
GWT-TUD GmbHHannover Medical School; Hoffmann-La RocheCompleted
-
Kathelijn FischerRadboud University Medical Center; University Medical Center Groningen; Maastricht... and other collaboratorsRecruitingAdolescent | Child | Hemophilia A With Inhibitor | Adult | Hemophilia A Without Inhibitor | Hemophilia A, SevereNetherlands
-
Hoffmann-La RocheActive, not recruitingSevere Hemophilia A | Moderate Hemophilia ABrazil, Germany, Italy, Spain, United States, Turkey, United Kingdom, Tunisia, Canada, Hungary, Morocco, Serbia
-
Catalyst BiosciencesCompletedHemophilia A | Hemophilia B | Hemophilia A With Inhibitor | Hemophilia B With Inhibitor | Hemophilia A Without Inhibitor | Hemophilia B Without InhibitorBulgaria, Russian Federation
-
JW PharmaceuticalRecruitingHemophilia A With Inhibitor | Hemophilia A Without InhibitorKorea, Republic of
-
PfizerCompletedFactor VIII Deficiency, Congenital | Hemophilia A, Congenital | Factor 8 Deficiency, Congenital | Autosomal Hemophilia A | Classic Hemophilia
-
BioMarin PharmaceuticalRecruitingHemophilia A With Inhibitor | Hemophilia A With Anti Factor VIIIUnited States, United Kingdom, Taiwan, Israel, Korea, Republic of, South Africa, Brazil, Italy, Germany
-
American Thrombosis and Hemostasis NetworkTakeda; CSL Behring; OctapharmaCompletedHemophilia A | Hemophilia B | Hemophilia | Hemophilia A With Inhibitor | Haemophilia | Hemophilia B With Inhibitor | Haemophilia A Without Inhibitor | Haemophilia B Without InhibitorUnited States
-
BayerCompletedHemophilia A; Hemophilia BIsrael
Clinical Trials on no intervention
-
Wave NeuroscienceCompletedAutistic DisorderUnited States
-
University of Alabama at BirminghamCompletedInflammatory Bowel Diseases | Colorectal Cancer | Diverticular Diseases | Social BehaviorUnited States
-
Janssen Research & Development, LLCCompletedLupus Erythematosus, Systemic | Lupus Erythematosus, Cutaneous | Lupus Erythematosus, DiscoidUnited States, Poland
-
Hospital Universitario La Paz3MVX CCB and Agaplesion Markus Krankenhaus, Frankfurt a.M., Germany.; Department...RecruitingEmbolism | Atrial Fibrillation | Arrhythmia | Stroke, Acute | Stroke Sequelae | AblationSpain
-
Southern California College of Optometry at Marshall...Ohio State University; University of Houston; Alcon Research; University of Waterloo and other collaboratorsCompletedContact Lens Complication | Contact Lens Acute Red Eye | Contact Lens Related Corneal Infiltrate (Disorder) | Contact Lens-Induced Corneal Fluorescein StainingUnited States, Canada
-
University of Dublin, Trinity CollegeCompleted
-
Hôpital Necker-Enfants MaladesUnknown
-
China Medical University HospitalUnknownIntention to Stay, Turnover Behavior
-
University of PittsburghCompletedChronic Low Back PainUnited States