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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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.

Conditions
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Hemophilia A

Intervention / Treatment
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* Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hemophilia A patients<br>Patients with hemophilia A who are being treated with Damoctocog alfa pegol (Jivi, BAY94-9027) in routine medical practice and are enrolled in Bayer-sponsored study NCT03932201 | Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)<br>* Intervention is given as part of routine medical practice<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of physical non-sedentary activity per week |  | 30 days at baseline | 
| Time of physical non-sedentary activity per week |  | 30 days at year 1 | 
| Time of physical non-sedentary activity per week |  | 30 days at year 2 | 
| Time of physical non-sedentary activity per week |  | 30 days at year 3 | 
| Category of physical non-sedentary activity | The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity | 30 days at baseline | 
| Category of physical non-sedentary activity | The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity | 30 days at year 1 | 
| Category of physical non-sedentary activity | The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity | 30 days at year 2 | 
| Category of physical non-sedentary activity | The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity | 30 days at year 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of physical activity per week by intensity | Intensity categories of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity | 30 days at each visit (baseline, year 1, 2 and 3) | 
| Time of physical activity per week by intensity stratified by sedentary and locomotion activity | Intensity categories of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity. Sedentary = yes/no; locomotion = yes/no | 30 days at each visit (baseline, year 1, 2 and 3) | 
| Association between physical activity time per week and annualized bleeding rate (ABR) | ABR from HEM-POWR study | 30 days at each visit (baseline, year 1, 2 and 3) | 
| Association between physical activity time per week and joint annualized bleeding rate (JABR) | JABR from HEM-POWR study | 30 days at each visit (baseline, year 1, 2 and 3) | 
| Association between physical activity time per week and hemophilia joint health score (HJHS) | HJHS from HEM-POWR study | 30 days at each visit (baseline, year 1, 2 and 3) | 
| Association between physical activity time per week and PRO-scores for treatment satisfaction | Patient reported outcome (PRO) scores from the Hemophilia Treatment Satisfaction Questionnaire for Adults collected in HEM-POWR study | 30 days at each visit (baseline, year 1, 2 and 3) | 
| Association between physical activity time per week and PRO-scores for health-related life quality | 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 | 30 days at each visit (baseline, year 1, 2 and 3) | 
| Association between physical activity time per week and PRO-scores for work productivity/ activity impairment | Patient reported outcome (PRO) scores from the Work Productivity and Activity Impairment Scale questionnaire collected in HEM-POWR study | 30 days at each visit (baseline, year 1, 2 and 3) | 
| Percentage of children (under 18) with ≥60 min per day of moderate to vigorous intensity physical activity |  | 30 days at each visit (baseline, year 1, 2 and 3) | 
| 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 |  | 30 days at each visit (baseline, year 1, 2 and 3) | 
| Repeated measure correlation between change in amount of non-sedentary physical activity time per week and change in annualized bleeding rate (ABR) | ABR from HEM-POWR study | 30 days at each visit (baseline, year 1, 2 and 3) | 
| Repeated measure correlation between change in amount of non-sedentary physical activity time per week and change in joint annualized bleeding rate (JABR) | JABR from HEM-POWR study | 30 days at each visit (baseline, year 1, 2 and 3) | 
| Actual wear time per week |  | 30 days at each visit (baseline, year 1, 2 and 3) | 
| Percentage of actual wear time per week |  | 30 days at each visit (baseline, year 1, 2 and 3) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical activity, Coagulation factor VIII, Joint health