Evaluating Effectiveness and Long Term Safety of Damoctocog Alfa Pegol in Patients, Who Have Been Diagnosed With Hemophilia A
Purpose
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.
Condition
- Hemophilia A
Eligibility
- Eligible Ages
- All ages
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| Previously treated patient (PTPs) with hemophilia A | Previously treated patients with hemophilia A receiving damoctocog alfa pegol with any kind of treatment modality (on-demand, prophylaxis, or intermittent prophylaxis)。 |
|
Recruiting Locations
Tulane University
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
More Details
- Status
- Recruiting
- Sponsor
- Bayer