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

Bayer

Status: Active, not recruiting

Conditions: Hemophilia A

Treatments: Drug: Damoctocog alfa pegol (Jivi, Bay94-9027)

Study type: Observational

Funder types: Industry

Identifiers

NCT03932201

20002

Details and patient eligibility

About

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.

Enrollment: 371 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

371 participants in 1 patient group

Previously treated patient (PTPs) with hemophilia A

Description:

Previously treated patients with hemophilia A receiving damoctocog alfa pegol with any kind of treatment modality (on-demand, prophylaxis, or intermittent prophylaxis)。

Treatment:

Drug: Damoctocog alfa pegol (Jivi, Bay94-9027)