A Registry for Factor X Deficiency to Define Natural History and Improve Care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational registry gathers information on people with congenital or acquired Factor X deficiency, documenting symptoms, laboratory findings, and treatment experiences. Data are collected over time to map disease patterns, outcomes, and current management practices. The goal is to inform evidence-based approaches and identify gaps in care. Participation requires informed consent and follow-up, with data used to support future research and clinical guidelines. The study is led by Fondazione Luigi Villa with collaborating centers in Italy.

Why it matters

Who can join: the full rules

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.

Where it's running

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

Study contacts

• Principal investigator: Flora Peyvandi, MD, PhD — Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
• Study coordinator: Flora Peyvandi, MD, PHD
• Email: contact@fondazioneluigivilla.org
• Phone: +39 02 55035414

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.