Hemophilia ALIFE-ACTIVENCT04091386
Study to Learn More About the Physical Activity Level of Patients Suffering From Hemophilia A Treated With Damoctocog Alfa Pegol (LIFE ACTIVE Study)
An observational study of Hemophilia A, run by Bayer at 8 sites in 7 countries.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Damoctocog alfa pegol (Jivi, BAY94-9027)
- How many people
- 10 participants
- Where
- 8 sitesin 7 countries
- Study dates
- 10 Jun 2021to 5 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with hemophilia A receiving damoctocog alfa pegol during Bayer-sponsored study NCT03932201
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
8 sites in 7 countries.
8 sites in 7 countries
United States2 sites
Tulane University
New Orleans, Louisiana, 70118
Center for Comprehensive Care and Diagnosis of Inherited Blood Disorders
Orange, California, 92868
About this 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.
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.
Read the 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.
- Conditions
- Hemophilia A
- Being tested
- Damoctocog alfa pegol (Jivi, BAY94-9027)
- Keywords
- Physical activity, Coagulation factor VIII, Joint health
- Medical subject headings
- Hemophilia A, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Damoctocog alfa pegol (Jivi, BAY94-9027)Drug
Intervention is given as part of routine medical practice
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: Damoctocog alfa pegol (Jivi, BAY94-9027) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time of physical non-sedentary activity per week
Measured: 30 days at baseline
Time of physical non-sedentary activity per week
Measured: 30 days at year 1
Time of physical non-sedentary activity per week
Measured: 30 days at year 2
Time of physical non-sedentary activity per week
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days at year 3
Secondary outcomes (14)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days at each visit (baseline, year 1, 2 and 3)
Actual wear time per week
Measured: 30 days at each visit (baseline, year 1, 2 and 3)
Percentage of actual wear time per week
Measured: 30 days at each visit (baseline, year 1, 2 and 3)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start10 Jun 2021
- Primary completion7 May 2024
- Study completion5 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemophilia AStudies of the same condition, open and under way.
- More trials run by BayerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04091386
- Sponsor's protocol ID
- 20748
- Acronym
- LIFE-ACTIVE
- Status last verified
- Jun 2025
- First submitted
- 30 Aug 2019
- Last updated
- 15 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT04091386
- Acronym / sponsor ID
- LIFE-ACTIVE / 20748
- Conditions
- Hemophilia A
- Keywords
- Physical activity, Coagulation factor VIII, Joint health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 10 Jun 2021 (actual)
- Primary completion
- 7 May 2024 (actual)
- Study completion
- 5 Jul 2024 (actual)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hemophilia A patients | – | Drug: Damoctocog alfa pegol (Jivi, BAY94-9027)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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with hemophilia A receiving damoctocog alfa pegol during Bayer-sponsored study NCT03932201
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Damoctocog alfa pegol (Jivi, BAY94-9027)Intervention is given as part of routine medical practice | Drug | Hemophilia A patients |
Primary outcome
Time of physical non-sedentary activity per week
Time frame: 30 days at baseline
Time of physical non-sedentary activity per week
Time frame: 30 days at year 1
Time of physical non-sedentary activity per week
Time frame: 30 days at year 2
Time of physical non-sedentary activity per week
Time frame: 30 days at year 3
Category of physical non-sedentary activity
Time frame: 30 days at baseline
The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity
Category of physical non-sedentary activity
Time frame: 30 days at year 1
The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity
Category of physical non-sedentary activity
Time frame: 30 days at year 2
The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity
Category of physical non-sedentary activity
Time frame: 30 days at year 3
The intensity of physical activity are: combined moderate to vigorous intensity, light intensity, moderate intensity, and vigorous intensity
14 secondary outcomes
Time of physical activity per week by intensity
Time 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
Time frame: 30 days at each visit (baseline, year 1, 2 and 3)
Association between physical activity time per week and annualized bleeding rate (ABR)
Time 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)
Time 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)
Time 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
Time 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
Time 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
Time 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
Time 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
Time 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)
Time 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)
Time frame: 30 days at each visit (baseline, year 1, 2 and 3)
Actual wear time per week
Time frame: 30 days at each visit (baseline, year 1, 2 and 3)
Percentage of actual wear time per week
Time frame: 30 days at each visit (baseline, year 1, 2 and 3)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2025.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hemophilia A, run by Bayer at 8 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Belgium, Canada, Italy, Slovenia and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time of physical non-sedentary activity per week (time frame: 30 days at baseline). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jun 2025.