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Clinical Trials in Ireland / NCT06940830
Recruiting Phase 4

Long-term Study Evaluating Joint Health in People With Haemophilia A Receiving Real-world Prophylactic Treatment With Efanesoctocog Alfa

NCT06940830 · tracked via the Priya Life Science Ireland tracker
Sponsor
Swedish Orphan Biovitrum
Phase
Phase 4
Started
2025-05-21
Last updated
2026-06-30

Condition(s) studied

Hemophilia A

Investigational drug(s) / intervention(s)

Efanesoctocog alfa

Efanesoctocog alfa: Participant in this study must be prescribed efanesoctocog alfa prophylactic treatment per their standard of care from their physician. No drug will be provided by the Sponsor.

Study summary

The rationale for this study is to further understand and describe the long-term prophylactic effectiveness of efanesoctocog alfa in preventing joint bleeds in a real-life setting.

Eligibility

Sex
ALL
Min age
Max age
Healthy volunteers
No
Inclusion Criteria: 1. Male or female patient with a diagnosis of haemophilia A. 2. Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol. 3. Prescribed with efanesoctocog alfa prophylactic treatment within 6 months prior to study enrolment or at the latest at the enrolment visit, in accordance with local regulations. 4. Must have received prophylactic treatment(s) with any haemophilia product(s) for at least 12 months prior to being prescribed with efanesoctocog alfa treatment. 5. Have documented pre-study treatment data on haemophilia prophylaxis prescriptions and on treated bleeding episodes from the 12-months prior to being prescribed efanesoctocog alfa treatment and until enrolment into this study. 6. Willing to adhere to the visit schedule and to undergo mandatory study assessment (HJHS, PROs). 7. Willingness and the ability of the patient or their legally designated representative to document all bleeding episodes, including any treatments for those episodes. 8. For HEAD-US subgroup: Accept to undergo annual ultrasound assessment on the index joints (ankles, elbows, knees). Exclusion Criteria: 1. Acquired haemophilia A and other blood clotting disorders than hereditary haemophilia A. 2. Any positive FVIII inhibitor result (defined as inhibitor titre ≥0.6 Bethesda unit \[BU\]/mL) from the medical records in connection to the switch to efanesoctocog alfa until the enrolment visit. 3. Enrolment in a concurrent clinical interventional study, or intake of an investigational medicinal product (IMP), including for haemophilia prophylaxis, within 3 months prior to enrolment in this study. 4. Patient not suitable for participation, whatever the reason, as judged by the Investigator, e.g., patient is not able or willing to perform the study assessments.

Primary outcome measure(s)

Trial sites (29)

FacilityCityRegionStatus
Sobi Investigational Site Zagreb Croatia Recruiting
Sobi Investigational Site Brno Czechia Recruiting
Sobi Investigational Site Ostrava Czechia Recruiting
Sobi Investigational Site Prague Czechia Recruiting
Sobi Investigational Site Bordeaux France Recruiting
Sobi Investigational Site Marseille France Recruiting
Sobi Investigational Site Montpellier France Recruiting
Sobi Investigational Site Nantes France Recruiting
Sobi Investigational Site Paris France Recruiting
Sobi Investigational Site Rennes France Recruiting
Sobi Investigational Site Rouen France Recruiting
Sobi Investigational Site Berlin Germany Recruiting
Sobi Investigational Site Bonn Germany Recruiting
Sobi Investigational Site Frankfurt am Main Germany Recruiting
Sobi Investigational Site Hamburg Germany Recruiting
Sobi Investigational Site Munich Germany Recruiting
Sobi Investigational Site Dublin Ireland Recruiting
Sobi Investigational Site Catania Italy Recruiting
Sobi Investigational Site Padua Italy Recruiting
Sobi Investigational Site Turin Italy Recruiting
Sobi Investigational Site A Coruña Spain Recruiting
Sobi Investigational Site Barcelona Spain Recruiting
Sobi Investigational Site Málaga Spain Recruiting
Sobi Investigational Site Palma de Mallorca Spain Recruiting
Sobi Investigational Site Zaragoza Spain Recruiting
Sobi Investigational Site Birmingham United Kingdom Recruiting
Sobi Investigational Site Cardiff United Kingdom Recruiting
Sobi Investigational Site London United Kingdom Recruiting
Sobi Investigational Site Manchester United Kingdom Recruiting

Other trials for the same condition

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 NCT06940830 on ClinicalTrials.gov ↗ ← All trials in Ireland