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)

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.

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.

Study Overview

• Status: Completed
• Conditions: Hemophilia A
• Intervention / Treatment: Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)

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
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• Belgium
  • Multiple Locations, Belgium
    • Many Locations
• Canada
  • Multiple Locations, Canada
    • Many Locations
• Italy
  • Multiple Locations, Italy
    • Many Locations
• Slovenia
  • Multiple Locations, Slovenia
    • Many Locations
• Spain
  • Multiple Locations, Spain
    • Many Locations
• Taiwan
  • Multiple Locations, Taiwan
    • Many Locations
• United States
  • California
    • Orange, California, United States, 92868
      • Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders
  • Louisiana
    • New Orleans, Louisiana, United States, 70118
      • Tulane University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with hemophilia A receiving damoctocog alfa pegol during Bayer-sponsored study NCT03932201

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of physical non-sedentary activity per week		30 days at baseline
Time of physical non-sedentary activity per week		30 days at year 1
Time of physical non-sedentary activity per week		30 days at year 2
Time of physical non-sedentary activity per week		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	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	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	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	30 days at year 3

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Actual wear time per week		30 days at each visit (baseline, year 1, 2 and 3)
Percentage of actual wear time per week		30 days at each visit (baseline, year 1, 2 and 3)

Collaborators and Investigators

• Sponsor: Bayer

Publications and helpful links

Helpful Links

• Click here to find information for studies related to Bayer products. To find this study enter the ClinicalTrials.gov identifier (NCT) number or Bayer Study Identifier (ID) in the search field.

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2021
• Primary Completion (Actual): May 7, 2024
• Study Completion (Actual): July 5, 2024

Study Registration Dates

• First Submitted: August 30, 2019
• First Submitted That Met QC Criteria: September 13, 2019
• First Posted (Actual): September 16, 2019

Study Record Updates

• Last Update Posted (Actual): June 15, 2025
• Last Update Submitted That Met QC Criteria: June 13, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Physical activity; Joint health; Coagulation factor VIII
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Hematologic Diseases; Blood Coagulation Disorders; Hemorrhagic Disorders; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemophilia A; Coagulants; Factor VIII
• Other Study ID Numbers: 20748 (Arthritis Research UK)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No