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

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• Hemophilia A 866

Keywords

• Physical activity
• Coagulation factor VIII
• Joint health

Hemophilia A

866 studies on the registry are indexed under Hemophilia A; 137 are open to participants now.

This study's enrollment of 10 is below the median of 80 across 314 observational studies indexed under Hemophilia A.

Lead sponsor

Bayer is the lead sponsor of 1,643 studies on the registry; 57 are open to participants now.

Of its 209 completed or terminated interventional studies of FDA-regulated products, 129 (62%) have results posted.

Study population

Groups and cohorts

• Hemophilia A patients

  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)

Interventions

• DrugDamoctocog alfa pegol (Jivi, BAY94-9027)

  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

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

   Time frame: 30 days at baseline

6. Category of physical non-sedentary activity

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

   Time frame: 30 days at year 1

7. Category of physical non-sedentary activity

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

   Time frame: 30 days at year 2

8. Category of physical non-sedentary activity

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

   Time frame: 30 days at year 3

Secondary outcomes

1. 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

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

2. 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

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

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

   ABR from HEM-POWR study

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

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

   JABR from HEM-POWR study

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

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

   HJHS from HEM-POWR study

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

6. 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

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

7. 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

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

8. 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

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

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)

    ABR from HEM-POWR study

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

12. 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

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

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)

Related links

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Individual participant data

Plan to share: No — Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access. As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014. Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.