NCT07314983

Brief Summary

To date, and to our knowledge, no case of severe hemophilia A patients receiving long-term anticoagulation has been published. Severe hemophilia A is a hereditary bleeding disorder characterized by a factor VIII (FVIII) deficiency of \<1%. Anticoagulation remains a real challenge in these patients, given the precarious hemostatic balance between the bleeding risk associated with anticoagulation and the antithrombotic protection associated with factor VIII deficiency. The advent of new replacement therapies, characterized by FVIII molecules with a prolonged or very prolonged half-life, provides a high level of FVIII coverage (and therefore protection against the risk of bleeding) in patients receiving prophylaxis, thus facilitating the initiation of anticoagulation therapy.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 22, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 22, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2026

Completed
Last Updated

January 2, 2026

Status Verified

September 1, 2025

Enrollment Period

3 months

First QC Date

September 22, 2025

Last Update Submit

December 31, 2025

Conditions

Keywords

Hemophilia ASevere Hemophilia Afactor VIII (FVIII) deficiencyAntithrombotic protectionAnticoagulant therapy

Outcome Measures

Primary Outcomes (1)

  • FVIII Level

    Factor VIII (FVIII) is a clotting protein: it enables the blood to form a clot to stop bleeding. Its level indicates how well the blood clots, which is useful for diagnosing or monitoring hemophilia A before surgery. General values: * Normal: approximately 50 to 150% * Too low: risk of bleeding * Too high: may increase the risk of clots

    Up to 15 months

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patient (≥ 18 years) with severe hemophilia A

You may qualify if:

  • Adult patient (≥ 18 years) with severe hemophilia A
  • Absence of written objection in the subject's medical record to the reuse of their data for scientific research purposes.

You may not qualify if:

  • \- Subject having expressed objection to the reuse of their data for scientific research

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laboratoire d'Hématologie - Unité d'Hémostase - CHU de Strasbourg - France

Strasbourg, 67091, France

RECRUITING

MeSH Terms

Conditions

Hemophilia A

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 22, 2025

First Posted

January 2, 2026

Study Start

September 22, 2025

Primary Completion

January 1, 2026

Study Completion

January 31, 2026

Last Updated

January 2, 2026

Record last verified: 2025-09

Locations