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Evaluating the long-term effects of efanesoctocog alfa on joint health in hemophilia A patients

Prospective, Observational , Multicenter Study of Effectiveness of Efanesoctocog Alfa on Long-term Joint Health in Patients With Hemophilia A

Observational Sanofi · NCT05911763

This study is testing how well efanesoctocog alfa helps protect joint health in people with hemophilia A over a long period of time.

Quick facts

Study typeObservational
Enrollment200 (estimated)
SexAll
SponsorSanofi Industry-sponsored
Locations27 sites (Gilbert, Arizona and 26 other locations)
Trial IDNCT05911763 on ClinicalTrials.gov

What this trial studies

This observational study aims to assess the real-world effectiveness, safety, and treatment usage of efanesoctocog alfa in patients diagnosed with hemophilia A. Participants will be enrolled after starting treatment with efanesoctocog alfa, with data collected during routine medical visits over a period of up to five years. The study will take place across multiple centers in the US and Japan, focusing on patients treated according to standard care protocols. The decision to initiate treatment is made independently by the physician, ensuring that the study does not influence clinical decisions.

Who should consider this trial

Good fit: Ideal candidates are patients diagnosed with hemophilia A who are starting treatment with efanesoctocog alfa.

Not a fit: Patients with other known bleeding disorders or those participating in other investigational trials may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the long-term joint health outcomes for patients with hemophilia A treated with efanesoctocog alfa.

How similar studies have performed: While this approach is observational, similar studies have shown promise in evaluating treatment effectiveness in hemophilia, though the specific use of efanesoctocog alfa is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Have a diagnosis of hemophilia A
* Patients starting efanesoctocog alfa treatment as per standard of care no more than one month prior to the enrollment date, for either on demand or prophylaxis. Patients starting efanesoctocog alfa treatment for a surgery event may also be enrolled only if the treatment is prescribed at enrollment.
* Physician's decision to treat the patient with efanesoctocog alfa is made prior to and independently of participation in the study.
* Signed and dated informed consent provided by the patient, or by the patient's legally acceptable representative for patients under the legal age before any study-related activities are undertaken. Assent should be obtained for pediatric patients according to local regulations.

Exclusion Criteria:

Diagnosed with other known bleeding disorder

* Participation in an investigational medicinal product trial at enrollment visit, or intake of an Investigational Medicinal Product within 3 months prior to inclusion in this study
* Current diagnosis of a FVIII inhibitor, defined as inhibitor titer ≥0.60 BU/mL

"The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial."

Where this trial is running

Gilbert, Arizona and 26 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Hemophilia A
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.