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)

• ClinicalTrials.gov Identifier: NCT04091386
• Recruitment Status: Active, not recruiting
• First Posted: September 16, 2019
• Last Update Posted: April 19, 2024
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Tracking Information

• First Submitted Date: August 30, 2019
• First Posted Date: September 16, 2019
• Last Update Posted Date: April 19, 2024
• Actual Study Start Date: June 10, 2021
• Estimated Primary Completion Date: December 31, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 22, 2021)

• Time of physical non-sedentary activity per week [ Time Frame: 30 days at baseline ]
• Time of physical non-sedentary activity per week [ Time Frame: 30 days at year 1 ]
• Time of physical non-sedentary activity per week [ Time Frame: 30 days at year 2 ]
• Time of physical non-sedentary activity per week [ Time Frame: 30 days at year 3 ]
• 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
• 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
• 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
• 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

Original Primary Outcome Measures (submitted: September 13, 2019)

• Time of physical activity per week (wear-time adjusted) [ Time Frame: 30 days at baseline ]
• Time of physical activity per week (wear-time adjusted) [ Time Frame: 30 days at year 1 ]
• Time of physical activity per week (wear-time adjusted) [ Time Frame: 30 days at year 2 ]
• Time of physical activity per week (wear-time adjusted) [ Time Frame: 30 days at year 3 ]
• Category of physical activity [ Time Frame: 30 days at baseline ]
  The intensity of physical activity is ranked into 5 categories: sedentary, low intensity, light intensity, moderate intensity and vigorous intensity.
• Category of physical activity [ Time Frame: 30 days at year 1 ]
  The intensity of physical activity is ranked into 5 categories: sedentary, low intensity, light intensity, moderate intensity and vigorous intensity.
• Category of physical activity [ Time Frame: 30 days at year 2 ]
  The intensity of physical activity is ranked into 5 categories: sedentary, low intensity, light intensity, moderate intensity and vigorous intensity.
• Category of physical activity [ Time Frame: 30 days at year 3 ]
  The intensity of physical activity is ranked into 5 categories: sedentary, low intensity, light intensity, moderate intensity and vigorous intensity.

Current Secondary Outcome Measures (submitted: September 22, 2021)

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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) ]
• 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) ]
• 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
• 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
• Actual wear time per week [ Time Frame: 30 days at each visit (baseline, year 1, 2 and 3) ]
• Percentage of actual wear time per week [ Time Frame: 30 days at each visit (baseline, year 1, 2 and 3) ]

Original Secondary Outcome Measures (submitted: September 13, 2019)

• 1. Sleeping time per week (wear-time adjusted) [ Time Frame: 30 days at each visit (baseline, year 1, 2 and 3) ]
• 2. Awake time per week (wear-time adjusted) [ Time Frame: 30 days at each visit (baseline, year 1, 2 and 3) ]
• 3. Time of moderate to vigorous physical activity per week (wear-time adjusted) [ Time Frame: 30 days at each visit (baseline, year 1, 2 and 3) ]
• 4. 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
• 5. 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
• 6. 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
• 7. Repeated measure correlation 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
• 8. Repeated measure correlation 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
• 9. 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
• 10. 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
• 11. 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
• 12. Percentage of children with ≥60 min per day of moderate to vigorous physical activity [ Time Frame: 30 days at each visit (baseline, year 1, 2 and 3) ]
• 13. Percentage of adults with ≥150 min per week of moderate to vigorous physical activity or with ≥75 min per week of vigorous physical activity [ Time Frame: 30 days at each visit (baseline, year 1, 2 and 3) ]
• 14.Time of physical activity per week (wear-time adjusted) by subgroup [ Time Frame: 30 days at each visit (baseline, year 1, 2 and 3) ]
  Subgroups are formed with respect to disease severity, drug regimen, naivity to damoctocog alfa pegol, age, number of bleeds and target joints at baseline.
• 15. Category of physical activity by subgroup [ Time Frame: 30 days at each visit (baseline, year 1, 2 and 3) ]
  The intensity of physical activity is ranked into 5 categories: sedentary, low intensity, light intensity, moderate intensity and vigorous intensity. Subgroups are formed with respect to disease severity, drug regimen, naivity to damoctocog alfa pegol, age, number of bleeds and target joints at baseline.
• 16. Sleeping time per week [ Time Frame: 30 days at each visit (baseline, year 1, 2 and 3) ]
• 17. Awake time per week [ Time Frame: 30 days at each visit (baseline, year 1, 2 and 3) ]
• 18. Percentage of sleeping time [ Time Frame: 30 days at each visit (baseline, year 1, 2 and 3) ]
• 19. Percentage of awake time [ Time Frame: 30 days at each visit (baseline, year 1, 2 and 3) ]
• 20. Actual wear time per week [ Time Frame: 30 days at each visit (baseline, year 1, 2 and 3) ]
• 21. Percentage of actual wear time per day [ Time Frame: 30 days at each visit (baseline, year 1, 2 and 3) ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

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

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.

• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Patients with hemophilia A receiving damoctocog alfa pegol during Bayer-sponsored study NCT03932201
• Condition: Hemophilia A

Intervention

Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)

Intervention is given as part of routine medical practice

Study Groups/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

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

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: January 31, 2024): 7
• Original Estimated Enrollment (submitted: September 13, 2019): 80
• Estimated Study Completion Date: June 30, 2027
• Estimated Primary Completion Date: December 31, 2026 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Belgium, Canada, Italy, Slovenia, Spain, Taiwan, United States
• Removed Location Countries: Brazil, Colombia, Denmark, Germany, Kuwait, Luxembourg, Mexico, Netherlands, Norway, Saudi Arabia, Sweden, Switzerland, United Arab Emirates

Administrative Information

• NCT Number: NCT04091386
• Other Study ID Numbers: 20748
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

Plan Description

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.

• Current Responsible Party: Bayer
• Original Responsible Party: Same as current
• Current Study Sponsor: Bayer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Bayer
• Verification Date: April 2024