Clinical trial NCT04091386: 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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hemophilia A
Keywords: Physical activity
Coagulation factor VIII
Joint health
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2019-09-16
Enrollment: 10
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hemophilia A receiving damoctocog alfa pegol during Bayer-sponsored study NCT03932201

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.

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

Primary outcomes:
measure: Time of physical non-sedentary activity per week
timeFrame: 30 days at baseline
measure: Time of physical non-sedentary activity per week
timeFrame: 30 days at year 1
measure: Time of physical non-sedentary activity per week
timeFrame: 30 days at year 2
measure: Time of physical non-sedentary activity per week
timeFrame: 30 days at year 3
measure: Category of physical non-sedentary activity
timeFrame: 30 days at baseline
measure: Category of physical non-sedentary activity
timeFrame: 30 days at year 1
measure: Category of physical non-sedentary activity
timeFrame: 30 days at year 2
measure: Category of physical non-sedentary activity
timeFrame: 30 days at year 3
Secondary outcomes:
measure: Time of physical activity per week by intensity
timeFrame: 30 days at each visit (baseline, year 1, 2 and 3)
measure: Time of physical activity per week by intensity stratified by sedentary and locomotion activity
timeFrame: 30 days at each visit (baseline, year 1, 2 and 3)
measure: Association between physical activity time per week and annualized bleeding rate (ABR)
timeFrame: 30 days at each visit (baseline, year 1, 2 and 3)
measure: Association between physical activity time per week and joint annualized bleeding rate (JABR)
timeFrame: 30 days at each visit (baseline, year 1, 2 and 3)
measure: Association between physical activity time per week and hemophilia joint health score (HJHS)
timeFrame: 30 days at each visit (baseline, year 1, 2 and 3)
measure: Association between physical activity time per week and PRO-scores for treatment satisfaction
timeFrame: 30 days at each visit (baseline, year 1, 2 and 3)
measure: Association between physical activity time per week and PRO-scores for health-related life quality
timeFrame: 30 days at each visit (baseline, year 1, 2 and 3)
measure: Association between physical activity time per week and PRO-scores for work productivity/ activity impairment
timeFrame: 30 days at each visit (baseline, year 1, 2 and 3)
measure: Percentage of children (under 18) with ≥60 min per day of moderate to vigorous intensity physical activity
timeFrame: 30 days at each visit (baseline, year 1, 2 and 3)
measure: 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
timeFrame: 30 days at each visit (baseline, year 1, 2 and 3)
measure: Repeated measure correlation between change in amount of non-sedentary physical activity time per week and change in annualized bleeding rate (ABR)
timeFrame: 30 days at each visit (baseline, year 1, 2 and 3)
measure: Repeated measure correlation between change in amount of non-sedentary physical activity time per week and change in joint annualized bleeding rate (JABR)
timeFrame: 30 days at each visit (baseline, year 1, 2 and 3)
measure: Actual wear time per week
timeFrame: 30 days at each visit (baseline, year 1, 2 and 3)
measure: Percentage of actual wear time per week
timeFrame: 30 days at each visit (baseline, year 1, 2 and 3)
Other outcomes:
Locations:
city: Orange
country: United States
facility: Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders
state: California
city: New Orleans
country: United States
facility: Tulane University
state: Louisiana
city: Multiple Locations
country: Belgium
facility: Many Locations
city: Multiple Locations
country: Canada
facility: Many Locations
city: Multiple Locations
country: Italy
facility: Many Locations
city: Multiple Locations
country: Slovenia
facility: Many Locations
city: Multiple Locations
country: Spain
facility: Many Locations
city: Multiple Locations
country: Taiwan
facility: Many Locations
Study officials:
References: