Study to Learn More About the Physical Activity Level of Patients Suffering From Hemophilia A Treated With Damoctocog Alfa Pegol (LIFE ACTIVE Study)
- Conditions
- Hemophilia A
- Interventions
- Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)
- Registration Number
- NCT04091386
- Lead Sponsor
- Bayer
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 10
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Hemophilia A patients Damoctocog alfa pegol (Jivi, BAY94-9027) 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
- Primary Outcome Measures
Name Time Method Category of physical non-sedentary activity 30 days at year 3 The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity
Time of physical non-sedentary activity per week 30 days at year 3
- Secondary Outcome Measures
Name Time Method 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) Repeated measure correlation between change in amount of non-sedentary physical activity time per week and change in annualized bleeding rate (ABR) 30 days at each visit (baseline, year 1, 2 and 3) ABR from HEM-POWR study
Actual wear time per week 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 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
Association between physical activity time per week and hemophilia joint health score (HJHS) 30 days at each visit (baseline, year 1, 2 and 3) HJHS from HEM-POWR study
Association between physical activity time per week and PRO-scores for treatment satisfaction 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
Association between physical activity time per week and PRO-scores for health-related life quality 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
Association between physical activity time per week and annualized bleeding rate (ABR) 30 days at each visit (baseline, year 1, 2 and 3) ABR from HEM-POWR study
Repeated measure correlation between change in amount of non-sedentary physical activity time per week and change in joint annualized bleeding rate (JABR) 30 days at each visit (baseline, year 1, 2 and 3) JABR from HEM-POWR study
Percentage of actual wear time per week 30 days at each visit (baseline, year 1, 2 and 3) Time of physical activity per week by intensity 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
Association between physical activity time per week and joint annualized bleeding rate (JABR) 30 days at each visit (baseline, year 1, 2 and 3) JABR from HEM-POWR study
Association between physical activity time per week and PRO-scores for work productivity/ activity impairment 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
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)
Trial Locations
- Locations (3)
Many Locations
🇨🇳Multiple Locations, Taiwan
Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders
🇺🇸Orange, California, United States
Tulane University
🇺🇸New Orleans, Louisiana, United States