Extended‑ vs short‑half‑life clotting factor prophylaxis and its impact on treatment burden and psychosocial wellbeing in adults with hemophilia

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 is a multicentre ambispective cohort study enrolling 114 adults with hemophilia A or B who have been on a stable prophylactic regimen (either extended‑half‑life or short‑half‑life clotting factor concentrates) for at least six months. The primary outcome is perceived treatment burden measured with a validated treatment burden questionnaire, with secondary measures including self‑efficacy, adherence, sleep quality and health locus of control. Data will be collected from medical records and patient‑completed questionnaires to compare psychosocial profiles between the two treatment groups. Patients with inhibitors or major comorbidities that could confound psychosocial measures are excluded to focus the comparison on treatment type.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patients over 18 years of age.
* Patients with a medical diagnosis of hemophilia A or B.
* Patients who, regardless of disease phenotype (mild, moderate or severe), are receiving prophylactic treatment with recombinant or plasma clotting factor concentrates, either short half-life or extended half-life.
* Patients must have maintained the same treatment regimen (SHL or EHL) continuously for at least six months prior to participation.

Exclusion Criteria:

* Patients who have developed inhibitors or antibodies to FVIII or FIX concentrates.
* People with a concomitant diagnosis of other serious or disabling chronic diseases (neurological, oncological, severe psychiatric or rheumatological) that may interfere with the perceived burden of treatment, sleep quality, functionality or perception of self-efficacy.
* Patients with cognitive, linguistic or sensory impairments that prevent them from correctly understanding and completing the questionnaires.
* Patients who are participating in clinical trials or intensive monitoring programmes that may alter their perception of the treatment and generate biases in the evaluation.

Where it's running

• Universidad de Oviedo
  Oviedo, Principality of Asturias, Spain Recruiting

Study contacts

• Principal investigator: Rubén Cuesta-Barriuso, PhD — Universidad de Oviedo
• Study coordinator: Rubén Cuesta-Barriuso, PhD
• Email: cuestaruben@uniovi.es
• Phone: 0034 985103386

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Personalized Hemophilia Care Through Telemedicine and Adherence Monitoring

  This study tests a telemedicine-based program to closely monitor bleeding, ensure patients stick to their treatment plan, and personalize care for adults with hemophilia who use a smartphone.

  Recruiting Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico · Milan · NCT07867834

• Checks how well the Figure-of-Eight Walk and Weight-Bearing Lunge tests measure movement in adults with hemophilia

  This observational study tests two movement tests to see if they reliably reflect mobility in adults with hemophilia who have a history of joint bleeding.

  Recruiting Yuzuncu Yil University · Van · NCT07851922

• Multimodal Telerehabilitation vs Face-to-Face Care for Adults with Hemophilia and Chronic Pain

  This trial tests whether a 6-week telerehabilitation program combining pain education and therapeutic exercise works as well as in-person care for adults with hemophilia and chronic pain.

  Recruiting University of Chile · Santiago, Santiago Metropolitan · NCT07682519

• PCC treatment for hemophilia A patients with inhibitors

  This trial tests whether giving prothrombin complex concentrate (PCC) during bleeding episodes can stop bleeds in people aged 12–65 with hemophilia A who have inhibitors.

  Recruiting Phase 4 Institute of Hematology & Blood Diseases Hospital, China · Tianjin, Tianjin Municipality · NCT07406139

• Fitusiran prophylaxis for boys aged 1 to under 12 with severe hemophilia A or B

  This study tests whether fitusiran given as prophylaxis can reduce bleeding in boys aged 1 to under 12 with severe hemophilia A or B, with or without inhibitors.

  Recruiting at 37 sites Phase 3 Sanofi · Los Angeles, California and 36 other locations · NCT07285460

• High-altitude stem cell and bone marrow transplant registry on the Qinghai-Tibet Plateau

  This project will collect clinical data and blood/bone marrow samples from people having hematopoietic stem cell transplants on the Qinghai‑Tibet Plateau to see how high altitude affects transplant outcomes and recovery.

  Recruiting Affiliated Hospital of Qinghai University · Xining, Qinghai · NCT07205523

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.