Trial Condition(s):

Hemophilia A

Study to learn more about the physical activity level of patients suffering from hemophilia A treated with damoctocog alfa pegol (LIFE ACTIVE study) (LIFE-ACTIVE)

Bayer Identifier:

20748

ClinicalTrials.gov Identifier:

NCT04091386

EudraCT Number:

Not Available

Recruiting

Trial Purpose

In this study researcher want to learn more about the change of physical activity of hemophilia A patients treated with damoctocog alfa pegol. Patients enrolled in this study will be wearing a small device measuring daily active time. Researcher will compare these physical activity data with patient’s clinical data including bleeding events to gain information on how bleeding levels are related to the activity level of the patients.
The study aims to enroll about 80 patients who are at the same time also participating in the HEM-POWR study (NCT03932201) evaluating the effectiveness and safety of damoctocog alfa pegol.

Inclusion Criteria
- Enrolled in the HEM-POWR study (NCT03932201)
  - Naïve to damoctocog alfa pegol prior to enrollment to HEM-POWR study
  - Prescribed for prophylaxis treatment for hemophilia with damoctocog alfa pegol
  -  Patient is willing to wear the provided device
  - Signed informed consent/assent to participate in LIFE-ACTIVE: Observational study evaluating the physical activity in a subset of damoctocog alfa pegol treated Hemophilia A patients who are enrolled in the HEM-POWR study
Exclusion Criteria
- Hypersensitivity to any material of activity monitor (e.g. steel, rubber)
  - Time gap between enrollment to HEM-POWR study and enrollment to LIFE-ACTIVE study is greater than 6 months

Trial Summary

Enrollment Goal
80
Trial Dates
black-arrow
Phase
4
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

Many Locations

Many Locations, Taiwan, China

Status
Recruiting
 
Locations

Many Locations

Many Locations, Slovenia

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Not yet recruiting
 
Locations

Many Locations

Many Locations, Belgium

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Canada

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Colombia

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Italy

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Saudi Arabia

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Spain

Status
Not yet recruiting
 
Locations

Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders

Orange, United States, 92868

Status
Not yet recruiting
 
Locations

Tulane University

New Orleans, United States, 70118

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, United Arab Emirates

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Brazil

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Switzerland

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Germany

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Denmark

Status
Not yet 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, Netherlands

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Norway

Status
Not yet recruiting
 
Locations

Many Locations

Many Locations, Sweden

Status
Not yet recruiting
 

Trial Design