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:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Many Locations Many Locations, Taiwan, China | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Slovenia | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Belgium | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Canada | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Italy | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Many Locations Many Locations, Spain | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders Orange, United States, 92868 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Locations Tulane University New Orleans, United States, 70118 | Contact Us: E-mail: [email protected] Phone: (+)1-888-84 22937 |
Trial Design
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.
Trial Type:
Observational
Intervention Type:
Drug
Trial Purpose:
N/A
Allocation:
N/A
Blinding:
N/A
Assignment:
N/A
Trial Arms:
1
Primary Outcome
- Time of physical non-sedentary activity per weekTimeframe: 30 days at baseline
- Time of physical non-sedentary activity per weekTimeframe: 30 days at year 1
- Time of physical non-sedentary activity per weekTimeframe: 30 days at year 2
- Time of physical non-sedentary activity per weekTimeframe: 30 days at year 3
- Category of physical non-sedentary activityThe intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensityTimeframe: 30 days at baseline
- Category of physical non-sedentary activityThe intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensityTimeframe: 30 days at year 1
- Category of physical non-sedentary activityThe intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensityTimeframe: 30 days at year 2
- Category of physical non-sedentary activityThe intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensityTimeframe: 30 days at year 3
Secondary Outcome
- Time of physical activity per week by intensityIntensity categories of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensityTimeframe: 30 days at each visit (baseline, year 1, 2 and 3)
- Time of physical activity per week by intensity stratified by sedentary and locomotion activityIntensity categories of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity. Sedentary = yes/no; locomotion = yes/noTimeframe: 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 studyTimeframe: 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 studyTimeframe: 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 studyTimeframe: 30 days at each visit (baseline, year 1, 2 and 3)
- Association between physical activity time per week and PRO-scores for treatment satisfactionPatient reported outcome (PRO) scores from the Hemophilia Treatment Satisfaction Questionnaire for Adults collected in HEM-POWR studyTimeframe: 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 qualityPatient 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 studyTimeframe: 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 impairmentPatient reported outcome (PRO) scores from the Work Productivity and Activity Impairment Scale questionnaire collected in HEM-POWR studyTimeframe: 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 activityTimeframe: 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 activityTimeframe: 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 studyTimeframe: 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 studyTimeframe: 30 days at each visit (baseline, year 1, 2 and 3)
- Actual wear time per weekTimeframe: 30 days at each visit (baseline, year 1, 2 and 3)
- Percentage of actual wear time per weekTimeframe: 30 days at each visit (baseline, year 1, 2 and 3)
Additional Information
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