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NCT Number: NCT04091386

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

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.

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Key information

Conditions

Hemophilia A Behavior Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders Motor Activity

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Multiple Locations, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Damoctocog alfa pegol (Jivi, Bay94-9027)

Drug

Intervention is given as part of routine medical practice

Primary outcomes

  1. Time of physical non-sedentary activity per week

    Time frame: 30 days at baseline

  2. Time of physical non-sedentary activity per week

    Time frame: 30 days at year 1

  3. Time of physical non-sedentary activity per week

    Time frame: 30 days at year 2

  4. Time of physical non-sedentary activity per week

    Time frame: 30 days at year 3

  5. Category of physical non-sedentary activity

    Time frame: 30 days at baseline

    The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity

  6. Category of physical non-sedentary activity

    Time frame: 30 days at year 1

    The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity

  7. Category of physical non-sedentary activity

    Time frame: 30 days at year 2

    The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity

  8. Category of physical non-sedentary activity

    Time frame: 30 days at year 3

    The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity

Secondary outcomes

  1. Time of physical activity per week by intensity

    Time frame: 30 days at each visit (baseline, year 1, 2 and 3)

    Intensity categories of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity

  2. Time of physical activity per week by intensity stratified by sedentary and locomotion activity

    Time frame: 30 days at each visit (baseline, year 1, 2 and 3)

    Intensity categories of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity. Sedentary = yes/no; locomotion = yes/no

  3. Association between physical activity time per week and annualized bleeding rate (ABR)

    Time frame: 30 days at each visit (baseline, year 1, 2 and 3)

    ABR from HEM-POWR study

  4. Association between physical activity time per week and joint annualized bleeding rate (JABR)

    Time frame: 30 days at each visit (baseline, year 1, 2 and 3)

    JABR from HEM-POWR study

  5. Association between physical activity time per week and hemophilia joint health score (HJHS)

    Time frame: 30 days at each visit (baseline, year 1, 2 and 3)

    HJHS from HEM-POWR study

  6. Association between physical activity time per week and PRO-scores for treatment satisfaction

    Time frame: 30 days at each visit (baseline, year 1, 2 and 3)

    Patient reported outcome (PRO) scores from the Hemophilia Treatment Satisfaction Questionnaire for Adults collected in HEM-POWR study

  7. Association between physical activity time per week and PRO-scores for health-related life quality

    Time frame: 30 days at each visit (baseline, year 1, 2 and 3)

    Patient reported outcome (PRO) scores from the Hemophilia Quality Life Measures for adults and Hemophilia Quality of Life short form for children questionnaires collected in HEM-POWR study

  8. Association between physical activity time per week and PRO-scores for work productivity/ activity impairment

    Time frame: 30 days at each visit (baseline, year 1, 2 and 3)

    Patient reported outcome (PRO) scores from the Work Productivity and Activity Impairment Scale questionnaire collected in HEM-POWR study

  9. Percentage of children (under 18) with ≥60 min per day of moderate to vigorous intensity physical activity

    Time frame: 30 days at each visit (baseline, year 1, 2 and 3)

  10. Percentage of adults (age 18 to 64) with ≥150 min per week of moderate to vigorous intensity physical activity or with ≥75 min per week of vigorous intensity physical activity

    Time frame: 30 days at each visit (baseline, year 1, 2 and 3)

  11. Repeated measure correlation between change in amount of non-sedentary physical activity time per week and change in annualized bleeding rate (ABR)

    Time frame: 30 days at each visit (baseline, year 1, 2 and 3)

    ABR from HEM-POWR study

  12. Repeated measure correlation between change in amount of non-sedentary physical activity time per week and change in joint annualized bleeding rate (JABR)

    Time frame: 30 days at each visit (baseline, year 1, 2 and 3)

    JABR from HEM-POWR study

  13. Actual wear time per week

    Time frame: 30 days at each visit (baseline, year 1, 2 and 3)

  14. Percentage of actual wear time per week

    Time frame: 30 days at each visit (baseline, year 1, 2 and 3)

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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.

Acronym: LIFE-ACTIVE

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Sep 16, 2019
Registry last updated
Jun 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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