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OBS17523

  • Status
    Accepting Candidates
  • Age
    N/A - N/A
  • Sexes
    All
  • Healthy Volunteers
    No
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Objective

This is a prospective, observational, multi-center longitudinal cohort study to describe the real-world effectiveness, safety and treatment usage of efanesoctocog alfa in patients with hemophilia A treated per standard of care in the US and Japan.

Patients will be enrolled in the study after the introduction of efanesoctocog alfa in the hemophilia treatment landscape in each study country. Decision to initiate treatment with commercially available efanesoctocog alfa will be made by the treating physician independently from the decision to include patients in the study. No study medication is provided. The data related to efanesoctocog alfa effectiveness, safety and usage will be collected prospectively during routine visits (expected annual/semi-annual visits) for up to 5 years following enrollment /treatment initiation.

Details

Full study title Prospective, Observational, Multicenter Study of Effectiveness of Efanesoctocog Alfa on Long-term Joint Health in Patients with Hemophilia A
Protocol number OCR44563
ClinicalTrials.gov ID NCT05911763

Eligibility

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 鈮�0.60 BU/mL

"The above information is not intended to contain all considerations relevant to a

potential participation in a clinical trial."

Lead researcher

  • Tung T Wynn, MD
    Pediatric Hematologist/Oncologist (Child Cancer Specialist)
    Tung T Wynn

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  2. Step
    2

    Get screened to confirm eligibility

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  3. Step
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    Provide your consent to participate

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  4. Step
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