Trial Condition(s):

Hemophilia A

Evaluating effectiveness and long term safety of Damoctocog alfa pegol in patients, who have been diagnosed with Hemophilia A (HEM-POWR)

Bayer Identifier:

20002

ClinicalTrials.gov Identifier:

NCT03932201

EudraCT Number:

Not Available

Recruiting

Trial 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.

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 Summary

Enrollment Goal
200
Trial Dates
black-arrow
Phase
N/A
Could I receive a placebo?
No
Products
Jivi (Damoctocog, BAY94-9027)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Regents of University of Minnesota

Minneapolis, United States, 55454

Status
Recruiting
 
Locations

Many locations

Many locations, Japan

Status
Recruiting
 
Locations

Many locations

Many locations, Italy

Status
Recruiting
 
Locations

Many locations

Many locations, Spain

Status
Recruiting
 
Locations

Many locations

Many locations, Canada

Status
Recruiting
 
Locations

Many locations

Many locations, Belgium

Status
Recruiting
 
Locations

Many locations

Many locations, Netherlands

Status
Recruiting
 
Locations

Many locations

Many locations, Sweden

Status
Recruiting
 
Locations

Many locations

Many locations, Denmark

Status
Recruiting
 
Locations

Many locations

Many locations, Greece

Status
Recruiting
 
Locations

Many locations

Many locations, Taiwan, China

Status
Recruiting
 
Locations

Many locations

Many locations, Slovenia

Status
Recruiting
 
Locations

University California Davis

Davis, United States, 95616

Status
Recruiting
 
Locations

East Carolina University - Brody School of Medicine

Greenville, United States, 27834

Status
Recruiting
 
Locations

Tulane University

New Orleans, United States, 70112

Status
Recruiting
 
Locations

South Alabama Medical Science Foundation

Mobile, United States, 36688

Status
Recruiting
 
Locations

Orthopaedic Hospital DBA Orthopaedic Institute for Children

Los Angelos, United States, 90007

Status
Recruiting
 
Locations

The Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders

Orange, United States, 92868

Status
Recruiting
 
Locations

University of Colorado Hemophilia and Thrombosis Center

Aurora, United States, 80045

Status
Recruiting
 
Locations

Many locations

Many locations, Germany

Status
Recruiting
 
Locations

Many locations

Many locations, Switzerland

Status
Not yet recruiting
 
Locations

Banner MD Anderson Cancer Center

Phoenix, United States, 85012

Status
Recruiting
 
Locations

Georgetown University

Washington, United States, 20007

Status
Recruiting
 
Locations

Many locations

Many locations, Brazil

Status
Not yet recruiting
 
Locations

Many locations

Many locations, Colombia

Status
Recruiting
 
Locations

Many locations

Many locations, Kuwait

Status
Not yet recruiting
 
Locations

Many locations

Many locations, Luxembourg

Status
Not yet recruiting
 
Locations

Many locations

Many locations, Mexico

Status
Not yet recruiting
 
Locations

Many locations

Many locations, Norway

Status
Not yet recruiting
 
Locations

Many locations

Many locations, Portugal

Status
Not yet recruiting
 
Locations

Many locations

Many locations, Russia

Status
Not yet recruiting
 
Locations

Many locations

Many locations, Saudi Arabia

Status
Not yet recruiting
 
Locations

Many locations

Many locations, United Arab Emirates

Status
Not yet recruiting
 

Trial Design