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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)

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ClinicalTrials.gov Identifier: NCT04091386
Recruitment Status : Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
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 activity including sleep 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.


Condition or disease Intervention/treatment
Hemophilia A Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)

Detailed Description:

The primary objective is to evaluate the change in physical 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 combined moderate to vigorous physical activity,
  • Association between physical acitivities and clinical outcomes / patient-reported outcome scores/ number of bleeds,
  • Percentage of patients achieving WHO-recommended levels of activity
  • Category of physical activity
  • Sleeping/ awake time
  • Actual wear time.

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Cohort
Time Perspective: Prospective
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.
Estimated Study Start Date : October 31, 2019
Estimated Primary Completion Date : June 30, 2027
Estimated Study Completion Date : June 30, 2027


Group/Cohort Intervention/treatment
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)
Intervention is given as part of routine medical practice




Primary Outcome Measures :
  1. Time of physical activity per week (wear-time adjusted) [ Time Frame: 30 days at baseline ]
  2. Time of physical activity per week (wear-time adjusted) [ Time Frame: 30 days at year 1 ]
  3. Time of physical activity per week (wear-time adjusted) [ Time Frame: 30 days at year 2 ]
  4. Time of physical activity per week (wear-time adjusted) [ Time Frame: 30 days at year 3 ]
  5. 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.

  6. 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.

  7. 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.

  8. 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.


Secondary Outcome Measures :
  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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hemophilia A receiving damoctocog alfa pegol during Bayer-sponsored study NCT03932201
Criteria

Inclusion Criteria:

  • Enrolled in the HEM-POWR study (NCT03932201)
  • On prophylaxis treatment for hemophilia

Exclusion Criteria:

  • Hypersensitivity to any material of activity monitor (e.g. steel, rubber)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04091386


Contacts
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Contact: Bayer Clinical Trials Contact (+)1-888-84 22937 clinical-trials-contact@bayer.com

Sponsors and Collaborators
Bayer

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04091386     History of Changes
Other Study ID Numbers: 20748
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Availability of this study's data will 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.clinicalstudydatarequest.com 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 Study sponsors section of the portal.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Physical activity
Coagulation factor VIII
Joint health
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
Coagulants