NCT04091386

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.

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
7 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2019

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 16, 2019

Completed
1.7 years until next milestone

Study Start

First participant enrolled

June 10, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 7, 2024

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 5, 2024

Completed
Last Updated

June 15, 2025

Status Verified

June 1, 2025

Enrollment Period

2.9 years

First QC Date

August 30, 2019

Last Update Submit

June 13, 2025

Conditions

Hemophilia A

Keywords

Physical activityCoagulation factor VIIIJoint health

Outcome Measures

Primary Outcomes (8)

  • 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 Outcomes (14)

  • Time of physical activity per week by 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

    30 days at each visit (baseline, year 1, 2 and 3)

  • Association between physical activity time per week and annualized bleeding rate (ABR)

    30 days at each visit (baseline, year 1, 2 and 3)

  • Association between physical activity time per week and joint annualized bleeding rate (JABR)

    30 days at each visit (baseline, year 1, 2 and 3)

  • Association between physical activity time per week and hemophilia joint health score (HJHS)

    30 days at each visit (baseline, year 1, 2 and 3)

  • +9 more secondary outcomes

Study Arms (1)

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)

Interventions

Damoctocog alfa pegol (Jivi, BAY94-9027)DRUG

Intervention is given as part of routine medical practice

Hemophilia A patients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders

Orange, California, 92868, United States

Location

Tulane University

New Orleans, Louisiana, 70118, United States

Location

Many Locations

Multiple Locations, Belgium

Location

Many Locations

Multiple Locations, Canada

Location

Many Locations

Multiple Locations, Italy

Location

Many Locations

Multiple Locations, Slovenia

Location

Many Locations

Multiple Locations, Spain

Location

Many Locations

Multiple Locations, Taiwan

Location

Related Links

MeSH Terms

Conditions

Hemophilia AMotor Activity

Interventions

Factor VIII

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesBehavior

Intervention Hierarchy (Ancestors)

Blood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2019

First Posted

September 16, 2019

Study Start

June 10, 2021

Primary Completion

May 7, 2024

Study Completion

July 5, 2024

Last Updated

June 15, 2025

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

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.

Locations

US(2)CA(1)ES(1)SL(1)IT(1)BE(1)TW(1)