Study to Learn More About the Physical Activity Level of Patients Suffering From Hemophilia A Treated With Damoctocog Alfa Pegol (LIFE ACTIVE Study)

  • End date
    Jun 30, 2027
  • participants needed
  • sponsor
Updated on 16 January 2022


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.


The primary objective is to evaluate the change in physical non-sedentary activity as measured by the ActiGraph CentrePoint Insight Watch (ActiGraph LLC, Pensacola, Florida) after 1, 2 and 3 years of treatment with damoctocog alfa pegol.

Secondary objectives are to determine the

  • Change in intensity of physical activity,
  • Association between physical activities and clinical outcomes / patient-reported outcome scores/ number of bleeds,
  • Percentage of patients achieving WHO-recommended levels of activity
  • Actual wear time.

Condition Hemophilia A
Treatment Damoctocog alfa pegol (Jivi, BAY94-9027)
Clinical Study IdentifierNCT04091386
Last Modified on16 January 2022


Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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