Summary

Location
at UC Davis
Dates
study started
completion around

Description

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.

Official Title

Observational Study Evaluating Effectiveness and Safety of Real-World Treatment With Damoctocog Alfa Pegol in Previously Treated Patients With Hemophilia A

Keywords

Hemophilia A, Factor VIII, Damoctocog alfa pegol (Jivi, Bay94-9027)

Eligibility

You can join if…

  • 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.

You CAN'T join if...

  • 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.

Locations

  • University California Davis
    Davis California 95616 United States
  • Orthopaedic Hospital DBA Orthopaedic Institute for Children
    Los Angeles California 90007 United States
  • The Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders
    Orange California 92868 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bayer
ID
NCT03932201
Study Type
Observational
Participants
About 371 people participating
Last Updated