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

NCT03932201 · tracked via the Priya Life Science USA tracker

Sponsor

Bayer

Phase

Observational

Started

2019-10-21

Last updated

2026-07-01

Condition(s) studied

Hemophilia A

Investigational drug(s) / intervention(s)

Damoctocog alfa pegol (Jivi, Bay94-9027)

Damoctocog alfa pegol (Jivi, Bay94-9027): Follow clinical practice. BAY94-9027 is a B-domain-deleted recombinant factor VIII (rFVIII) product site-specifically conjugated to a single (dual 30-kDa branched) 60-kDa polyethylene glycol (PEG) molecule. BAY 94-9027 is intended for prophylaxis and treatment of bleeds in patients with hemophilia A aged ≥12 years, with a narrow, predictable weekly dose that allows for the treatment regimen to be tailored to individual patient needs.

Study 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.

Eligibility

Sex

ALL

Min age

—

Max age

—

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.

Primary outcome measure(s)

Mean annualized number of reported total bleeds in patients with hemophilia A — Up to 36 months
Median annualized number of reported total bleeds in patients with hemophilia A — Up to 36 months

Trial sites (29)

Facility	City	Region
South Alabama Medical Science Foundation	Mobile	Alabama
Banner MD Anderson Cancer Center	Phoenix	Arizona
University California Davis	Davis	California
Orthopaedic Hospital DBA Orthopaedic Institute for Children	Los Angeles	California
The Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders	Orange	California
University of Colorado Hemophilia and Thrombosis Center	Aurora	Colorado
Georgetown University	Washington D.C.	District of Columbia
Tulane University	New Orleans	Louisiana
Regents of University of Minnesota	Minneapolis	Minnesota
East Carolina University - Brody School of Medicine	Greenville	North Carolina
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
Many locations	Multiple Locations	Sweden
Many locations	Multiple Locations	Switzerland
Many locations	Multiple Locations	Taiwan
Many locations	Multiple Locations	United Arab Emirates

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03932201 on ClinicalTrials.gov ↗ ← All trials in the USA