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

Running, not enrolling

Conditions studied: Hemophilia A

In brief

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.

Key facts

Study ID

NCT03932201

Run by

Bayer

People needed

371

Starts

2019-10-21

Expected to finish

2027-03-31

Last updated by the study team

2026-07-01

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify 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 may not qualify 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.

Where it is running

• South Alabama Medical Science Foundation — Mobile, Alabama, United States
• Banner MD Anderson Cancer Center — Phoenix, Arizona, United States
• University California Davis — Davis, California, United States
• Orthopaedic Hospital DBA Orthopaedic Institute for Children — Los Angeles, California, United States
• The Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders — Orange, California, United States
• University of Colorado Hemophilia and Thrombosis Center — Aurora, Colorado, United States
• Georgetown University — Washington D.C., District of Columbia, United States
• Tulane University — New Orleans, Louisiana, United States
• Regents of University of Minnesota — Minneapolis, Minnesota, United States
• East Carolina University - Brody School of Medicine — Greenville, North Carolina, United States
• Many locations — Multiple Locations, Belgium
• Many locations — Multiple Locations, Brazil
• Many locations — Multiple Locations, Canada
• Many locations — Multiple Locations, Colombia
• Many locations — Multiple Locations, Denmark
• Many locations — Multiple Locations, Germany
• Many locations — Multiple Locations, Greece
• Many locations — Multiple Locations, Italy
• Many locations — Multiple Locations, Japan
• Many locations — Multiple Locations, Kuwait
• Many locations — Multiple Locations, Netherlands
• Many locations — Multiple Locations, Norway
• Many locations — Multiple Locations, Saudi Arabia
• Many locations — Multiple Locations, Slovenia
• Many locations — Multiple Locations, Spain

Full record on ClinicalTrials.gov

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