Evaluating Effectiveness and Long Term Safety of Damoctocog Alfa Pegol in Patients, Who Have Been Diagnosed With Hemophilia A (HEM-POWR)

  • STATUS
    Recruiting
  • End date
    Sep 30, 2025
  • participants needed
    200
  • sponsor
    Bayer
Updated on 28 May 2022
antihemophilic factor
damoctocog alfa pegol
jivi

Summary

The aim of the HEM-POWR study is to understand better how Damoctocog alfa pegol (Jivi) is used to treat people with Hemophilia A in day-to-day life, how well the treatment is tolerated and how satisfied patients and physicians are with the treatment.

Details
Condition Hemophilia A
Treatment Damoctocog alfa pegol (Jivi, BAY94-9027)
Clinical Study IdentifierNCT03932201
SponsorBayer
Last Modified on28 May 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosis of hemophilia A
Patients previously treated for Hemophilia A
Patients without previous history of inhibitors or patients with previous history of inhibitors on standard prophylaxis therapy for at least 1 year prior to study entry
No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor
Initiation of or currently on damoctocog alfa pegol with any kind of treatment modality (on-demand, prophylaxis, or intermittent prophylaxis)
Signed informed consent/assent

Exclusion Criteria

Concurrent participation in an investigational program with interventions outside of routine clinical practice
Diagnosis of any other bleeding/coagulation disorder other than hemophilia A
Contra-indications according to the local marketing authorization
Patient on immune tolerance induction (ITI) treatment at the time of enrollment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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