do_not_disturb_altRecruitment Complete

Hemophilia A

Bayer Identifier:

20748

ClinicalTrials.gov Identifier:

NCT04091386

EudraCT Number:

Not Available

EU CT Number:

Not Available
Study to learn more about the physical activity level of patients suffering from hemophilia A treated with damoctocog alfa pegol (LIFE ACTIVE study)

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.

Key Participants Requirements

Sex

All

Age

NaN - N/A
  • - 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

Trial summary

Enrollment Goal
10
Trial Dates
June 2021 - June 2027
Phase
Phase 4
Could I Receive a placebo
No
Products
Jivi (Damoctocog, BAY94-9027)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Many LocationsMany Locations, Taiwan
Not yet recruiting
Many LocationsMany Locations, Slovenia
Not yet recruiting
Many LocationsMany Locations, Belgium
Completed
Many LocationsMany Locations, Canada
Withdrawn
Many LocationsMany Locations, Colombia
Completed
Many LocationsMany Locations, Italy
Withdrawn
Many LocationsMany Locations, Saudi Arabia
Not yet recruiting
Many LocationsMany Locations, Spain
Not yet recruiting
Center for Comprehensive Care and Diagnosis of Inherited Blood DisordersOrange, 92868, United States
Not yet recruiting
Tulane UniversityNew Orleans, 70118, United States
Withdrawn
Many LocationsMany Locations, United Arab Emirates
Withdrawn
Many LocationsMany Locations, Brazil
Withdrawn
Many LocationsMany Locations, Switzerland
Withdrawn
Many LocationsMany Locations, Germany
Withdrawn
Many LocationsMany Locations, Denmark
Withdrawn
Many LocationsMany Locations, Kuwait
Withdrawn
Many LocationsMany Locations, Luxembourg
Withdrawn
Many LocationsMany Locations, Mexico
Withdrawn
Many LocationsMany Locations, Netherlands
Withdrawn
Many LocationsMany Locations, Norway
Withdrawn
Many LocationsMany Locations, Sweden

Primary Outcome

  • Time of physical non-sedentary activity per week
    date_rangeTime Frame:
    30 days at baseline
  • Time of physical non-sedentary activity per week
    date_rangeTime Frame:
    30 days at year 1
  • Time of physical non-sedentary activity per week
    date_rangeTime Frame:
    30 days at year 2
  • Time of physical non-sedentary activity per week
    date_rangeTime Frame:
    30 days at year 3
  • Category of physical non-sedentary activity
    The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity
    date_rangeTime Frame:
    30 days at baseline
  • Category of physical non-sedentary activity
    The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity
    date_rangeTime Frame:
    30 days at year 1
  • Category of physical non-sedentary activity
    The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity
    date_rangeTime Frame:
    30 days at year 2
  • Category of physical non-sedentary activity
    The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity
    date_rangeTime Frame:
    30 days at year 3

Secondary Outcome

  • 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
    date_rangeTime Frame:
    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
    Intensity categories of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity. Sedentary = yes/no; locomotion = yes/no
    date_rangeTime Frame:
    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 study
    date_rangeTime Frame:
    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 study
    date_rangeTime Frame:
    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 study
    date_rangeTime Frame:
    30 days at each visit (baseline, year 1, 2 and 3)
  • 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
    date_rangeTime Frame:
    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 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
    date_rangeTime Frame:
    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 impairment
    Patient reported outcome (PRO) scores from the Work Productivity and Activity Impairment Scale questionnaire collected in HEM-POWR study
    date_rangeTime Frame:
    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 activity
    date_rangeTime 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
    date_rangeTime 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)
    ABR from HEM-POWR study
    date_rangeTime 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 joint annualized bleeding rate (JABR)
    JABR from HEM-POWR study
    date_rangeTime Frame:
    30 days at each visit (baseline, year 1, 2 and 3)
  • Actual wear time per week
    date_rangeTime Frame:
    30 days at each visit (baseline, year 1, 2 and 3)
  • Percentage of actual wear time per week
    date_rangeTime Frame:
    30 days at each visit (baseline, year 1, 2 and 3)

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
N/A

Additional Information

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