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

Hemophilia A Clinical Trial

— LIFE-ACTIVE  

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04091386
• Other study ID #: 20748
• Status: Active, not recruiting
• Start date: June 10, 2021
• Est. completion date: June 30, 2027

Study information

• Verified date: May 2024
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 7
• Est. completion date: June 30, 2027
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hemophilia A

Intervention

Drug:
• Damoctocog alfa pegol (Jivi, BAY94-9027)
Intervention is given as part of routine medical practice

Locations

Country	Name	City	State
Belgium	Many Locations	Multiple Locations
Canada	Many Locations	Multiple Locations
Italy	Many Locations	Multiple Locations
Slovenia	Many Locations	Multiple Locations
Spain	Many Locations	Multiple Locations
Taiwan	Many Locations	Multiple Locations
United States	Tulane University	New Orleans	Louisiana
United States	Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders	Orange	California

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Countries where clinical trial is conducted

United States,  Belgium,  Canada,  Italy,  Slovenia,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of physical non-sedentary activity per week		30 days at baseline
Primary	Time of physical non-sedentary activity per week		30 days at year 1
Primary	Time of physical non-sedentary activity per week		30 days at year 2
Primary	Time of physical non-sedentary activity per week		30 days at year 3
Primary	Category of physical non-sedentary activity	The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity	30 days at baseline
Primary	Category of physical non-sedentary activity	The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity	30 days at year 1
Primary	Category of physical non-sedentary activity	The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity	30 days at year 2
Primary	Category of physical non-sedentary activity	The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity	30 days at year 3
Secondary	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	30 days at each visit (baseline, year 1, 2 and 3)
Secondary	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	30 days at each visit (baseline, year 1, 2 and 3)
Secondary	Association between physical activity time per week and annualized bleeding rate (ABR)	ABR from HEM-POWR study	30 days at each visit (baseline, year 1, 2 and 3)
Secondary	Association between physical activity time per week and joint annualized bleeding rate (JABR)	JABR from HEM-POWR study	30 days at each visit (baseline, year 1, 2 and 3)
Secondary	Association between physical activity time per week and hemophilia joint health score (HJHS)	HJHS from HEM-POWR study	30 days at each visit (baseline, year 1, 2 and 3)
Secondary	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	30 days at each visit (baseline, year 1, 2 and 3)
Secondary	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	30 days at each visit (baseline, year 1, 2 and 3)
Secondary	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	30 days at each visit (baseline, year 1, 2 and 3)
Secondary	Percentage of children (under 18) with =60 min per day of moderate to vigorous intensity physical activity		30 days at each visit (baseline, year 1, 2 and 3)
Secondary	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		30 days at each visit (baseline, year 1, 2 and 3)
Secondary	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	30 days at each visit (baseline, year 1, 2 and 3)
Secondary	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	30 days at each visit (baseline, year 1, 2 and 3)
Secondary	Actual wear time per week		30 days at each visit (baseline, year 1, 2 and 3)
Secondary	Percentage of actual wear time per week		30 days at each visit (baseline, year 1, 2 and 3)

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