Ireland
--:--IST
Recruiting Observational

A Database For The Collection Of Clinical, Laboratory, And Treatment Data From Patients With Factor X Deficiency To Define The Natural History Of The Disease And Improve Patient Management

NCT07875478 · tracked via the Priya Life Science Italy tracker
Sponsor
Fondazione Luigi Villa
Phase
Observational
Started
2026-06-14
Last updated
2026-10-20

Condition(s) studied

Factor X Deficiency

Study summary

Factor X deficiency is one of the most severe rare bleeding disorders and may lead to serious spontaneous hemorrhages, particularly in patients with severe congenital forms. Acquired FX deficiency is even rarer, most frequently associated with AL amyloidosis, and remains poorly characterized. Establishing a comprehensive patient registry is essential to improve understanding of disease epidemiology, clinical manifestations, and treatment outcomes, ultimately supporting evidence-based management strategies.

Eligibility

Sex
ALL
Min age
—
Max age
—
Healthy volunteers
Accepted
Inclusion Criteria: * Presence of the informed consent to participate in the study and provide biological samples. NB: lack of consent to the storage of biological samples is not a reason for exclusion; * Males or females, of all ages, with congenital or acquired coagulation FX deficiency, diagnosed by FX:C values below the normal range; * First-degree family members of a person diagnosed with FX deficiency of all ages; * Willingness to participate in prospective follow-up. Exclusion Criteria: * Previous organ transplant recipient; * Any psychiatric disorder, other mental disorder, or any other medical disorder that impairs the subject's ability to give informed consent or to comply with the requirements of the study protocol (unless a caregiver or authorized representative is willing to provide consent/assent); * Special patient populations, including prisoners or those who are deemed medically or cognitively unsuitable for research by their treating physician; * Inability to obtain a blood sample due to poor or limited venous access; * Other coagulation factor deficiencies.

Primary outcome measure(s)

  • Bleedings — 3 years
    To estimate total bleed rates including major, minor, spontaneous and non-spontaneous episodes in patients with FX deficiency

Trial sites (2)

FacilityCityRegionStatus
Azienda Ospedaliero Universitaria Careggi. SODc Malattie Emorragiche e della Coagulazione Florence Italy Recruiting
Angelo Bianchi Bonomi, Hemophilia and Thrombosis Center Milan Italy Recruiting

More Fondazione Luigi Villa trials in Italy

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07875478 on ClinicalTrials.gov ↗ ← All trials in Italy