Hemophilia AHEM-POWR KidsNCT07088458
An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A
An observational study of Hemophilia A, run by Bayer at 12 sites in 11 countries.
Trial summary
This is an observational study of children with mild, moderate, or severe hemophilia A who are receiving damoctocog alfa pegol, and are between 7 to <12 years of age at the time of enrolment. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Hemophilia A
- What is being tested?
- Damoctocog alfa pegol (Jivi, Bay94-9027)
- How many people
- 40 participants
- Where
- 12 sitesin 11 countries
- Study dates
- 16 Jul 2026to 1 Mar 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients are to be enrolled from treatment centers specializing in the treatment of bleeding disorders in countries with market authorization for the use of damoctocog alfa pegol for patients aged >7 years.
Who may be able to join
- Diagnosis of hemophilia A
- Patients must be 7 to < 12 years of age at enrollment
- Patients previously treated for hemophilia A ((≥50 exposure days to FVIII)
- No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor
- Patients without a previous history of inhibitors or patients with a previous history of inhibitors on standard prophylaxis therapy for at least 1 year prior to study entry
- Initiation of prescription or currently prescribed damoctocog alfa pegol for regular continuous prophylaxis (intent to treat for 52 weeks/year)
- Signed informed consent/assent.
Who cannot join
- Presence of a FVIII inhibitor
- Concurrent participation in an investigational program with interventions outside of routine clinical practice
- Diagnosis of any other bleeding/coagulation disorder other than hemophilia A
- Use of another hemostatic agent as the primary method of bleeding prophylaxis during the observation period
- Contra-indications according to the local marketing authorization
- Current immune tolerance induction (ITI) treatment for a FVIII inhibitor
Trial locations and contacts
12 sites in 11 countries. Contact the study team or a site near you to ask about taking part.
12 sites in 11 countries
United States2 sites, 2 recruiting
- Not yet recruiting
Loma Linda University Health
Loma Linda, California, 92354
- Not yet recruiting
Rutgers, The State University
New Brunswick, New Jersey, 08901
About this study
This is an observational study of children with mild, moderate, or severe hemophilia A who are receiving damoctocog alfa pegol, and are between 7 to <12 years of age at the time of enrolment. Observational studies use data that are collected as part of routine medical care and participants do not receive any advice or any changes to healthcare as part of the study.
In this study, the data will be collected from participants who are receiving their usual treatment with damoctocog alfa pegol as prescribed by their doctor. These children have previously received damoctocog alfa pegol or other factor 8 (FVIII) products.
Read more
Hemophilia A is a genetic bleeding disorder. It is caused by the lack of a protein called clotting factor 8 (FVIII) that helps blood to clot properly. Lack of FVIII can result in excessive blood loss or bleeding inside the body after being injured or having surgery. At times, there is spontaneous bleeding into the joint spaces that leads to joint damage.
The drug observed in this study, damoctocog alfa pegol, is approved for doctors to prescribe to children who are at least 7 years old with hemophilia A. It is used to prevent or treat bleeding episodes and works by replacing missing FVIII in the body of people with hemophilia A.
The participants will receive damoctocog alfa pegol as prescribed independently by their own doctors during routine practice, not as a part of the study. Participants may choose to enroll in the study at any time after their doctor has prescribed damoctocog alfa pegol to prevent bleeding episodes.
The main purpose of this study is to learn more about how a treatment with damoctocog alfa pegol works to prevent bleeding episodes in routine medical practice. To answer this question, doctors will collect:
- information about bleeding episodes including the type and the location of the bleed
- information about the treatment with damoctocog alfa pegol and other FVIII products
- the overall health status of the participants
Data will be collected from participants over two years after they enroll in the study or until they choose to leave the study or switch to another hemophilia A treatment. Historical data will come from the participants' medical records or by interviewing the patient and parent/ legal guardian. The children's parents/ guardians will be asked to maintain a health diary to record details of bleeding episodes and treatment with damoctocog alfa pegol. The children's parents/ guardians will also be asked to answer a questionnaire (Hemo QoL-SF and PedHAL) to assess the effect of hemophilia on their child's daily life.
In this study, only available data from routine care will be collected. No additional visits or tests are required as part of this study.
- Conditions
- Hemophilia A
- Being tested
- Damoctocog alfa pegol (Jivi, Bay94-9027)
- Medical subject headings
- Hemophilia A
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
Follow clinical practice of BAY94-9027 to further define the treatment outcomes of damoctocog alfa pegol based on real-world use for regular prophylaxis in ages 7 to <12 years, including a broader population and a real-world treatment patterns.
| Study group | Role | What they receive |
|---|---|---|
| Previously treated patients (PTPs) with hemophilia A | Previously treated patients with hemophilia A who have been prescribed damoctocog alfa pegol for regular continuous prophylaxis. 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.
Number of treated bleeds per individual diary documentation period while prescribed damoctocog alfa pegol prophylaxis (overall and by dosing regimen)
Measured: Up to 24 months
Secondary outcomes (6)
Number of treated and all bleeds for the different bleed types (spontaneous, trauma, joint) per individual diary documentation period while prescribed damoctocog alfa pegol prophylaxis (overall and by dosing regimen)
Measured: Up to 24 months
Occurrence of bleeds during individual diary documentation period while prescribed damoctocog alfa pegol prophylaxis prescription (overall and by dosing regimen)
Measured: Up to 24 months
Occurrence of bleeds within 6 months' time intervals including the first and the last 6 months during observation period (overall and by dosing regimen)
Measured: Up to 24 months
Presence of target joints at enrollment and at end of prophylaxis prescription (overall and by dosing regimen)
Measured: Up to 24 months
Damoctocog alfa pegol dose per infusion (overall and by dosing regimen)
Measured: Up to 24 months
Number of FVIII infusions (overall and by dosing regimen)
Measured: Up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start16 Jul 2026
- Primary completion31 Dec 2029 (estimated)
- Study completion1 Mar 2030 (estimated)
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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bayer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07088458
- Sponsor's protocol ID
- 22991
- Acronym
- HEM-POWR Kids
- Status last verified
- Oct 2026
- First submitted
- 21 Jul 2025
- Last updated
- 26 Oct 2026
- 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 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A
- ClinicalTrials.gov ID
- NCT07088458
- Acronym / sponsor ID
- HEM-POWR Kids / 22991
- Conditions
- Hemophilia A
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- BayerIndustry (pharma, biotech, devices)
- Study start
- 16 Jul 2026 (actual)
- Primary completion
- 31 Dec 2029 (estimated)
- Study completion
- 1 Mar 2030 (estimated)
- First posted
- 28 Jul 2025 (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.
This is an observational study of children with mild, moderate, or severe hemophilia A who are receiving damoctocog alfa pegol, and are between 7 to <12 years of age at the time of enrolment. Observational studies use data that are collected as part of routine medical care and participants do not receive any advice or any changes to healthcare as part of the study.
In this study, the data will be collected from participants who are receiving their usual treatment with damoctocog alfa pegol as prescribed by their doctor. These children have previously received damoctocog alfa pegol or other factor 8 (FVIII) products.
Hemophilia A is a genetic bleeding disorder. It is caused by the lack of a protein called clotting factor 8 (FVIII) that helps blood to clot properly. Lack of FVIII can result in excessive blood loss or bleeding inside the body after being injured or having surgery. At times, there is spontaneous bleeding into the joint spaces that leads to joint damage.
The drug observed in this study, damoctocog alfa pegol, is approved for doctors to prescribe to children who are at least 7 years old with hemophilia A. It is used to prevent or treat bleeding episodes and works by replacing missing FVIII in the body of people with hemophilia A.
The participants will receive damoctocog alfa pegol as prescribed independently by their own doctors during routine practice, not as a part of the study. Participants may choose to enroll in the study at any time after their doctor has prescribed damoctocog alfa pegol to prevent bleeding episodes.
The main purpose of this study is to learn more about how a treatment with damoctocog alfa pegol works to prevent bleeding episodes in routine medical practice. To answer this question, doctors will collect:
- information about bleeding episodes including the type and the location of the bleed
- information about the treatment with damoctocog alfa pegol and other FVIII products
- the overall health status of the participants
Data will be collected from participants over two years after they enroll in the study or until they choose to leave the study or switch to another hemophilia A treatment. Historical data will come from the participants' medical records or by interviewing the patient and parent/ legal guardian. The children's parents/ guardians will be asked to maintain a health diary to record details of bleeding episodes and treatment with damoctocog alfa pegol. The children's parents/ guardians will also be asked to answer a questionnaire (Hemo QoL-SF and PedHAL) to assess the effect of hemophilia on their child's daily life.
In this study, only available data from routine care will be collected. No additional visits or tests are required as part of this study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Previously treated patients (PTPs) with hemophilia A | – | Drug: Damoctocog alfa pegol (Jivi, Bay94-9027)Previously treated patients with hemophilia A who have been prescribed damoctocog alfa pegol for regular continuous prophylaxis. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients are to be enrolled from treatment centers specializing in the treatment of bleeding disorders in countries with market authorization for the use of damoctocog alfa pegol for patients aged >7 years.
Key inclusion criteria (7 listed)
- Diagnosis of hemophilia A
- Patients must be 7 to < 12 years of age at enrollment
- Patients previously treated for hemophilia A ((≥50 exposure days to FVIII)
- No current evidence of FVIII inhibitor or clinical suspicion of FVIII inhibitor
- Patients without a previous history of inhibitors or patients with a previous history of inhibitors on standard prophylaxis therapy for at least 1 year prior to study entry
Key exclusion criteria (6 listed)
- Presence of a FVIII inhibitor
- Concurrent participation in an investigational program with interventions outside of routine clinical practice
- Diagnosis of any other bleeding/coagulation disorder other than hemophilia A
- Use of another hemostatic agent as the primary method of bleeding prophylaxis during the observation period
- Contra-indications according to the local marketing authorization
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)Follow clinical practice of BAY94-9027 to further define the treatment outcomes of damoctocog alfa pegol based on real-world use for regular prophylaxis in ages 7 to <12 years, including a broader population and a real-world treatment patterns. | Drug | Previously treated patients (PTPs) with hemophilia A |
Primary outcome
Number of treated bleeds per individual diary documentation period while prescribed damoctocog alfa pegol prophylaxis (overall and by dosing regimen)
Time frame: Up to 24 months
6 secondary outcomes
Number of treated and all bleeds for the different bleed types (spontaneous, trauma, joint) per individual diary documentation period while prescribed damoctocog alfa pegol prophylaxis (overall and by dosing regimen)
Time frame: Up to 24 months
Occurrence of bleeds during individual diary documentation period while prescribed damoctocog alfa pegol prophylaxis prescription (overall and by dosing regimen)
Time frame: Up to 24 months
Occurrence of bleeds within 6 months' time intervals including the first and the last 6 months during observation period (overall and by dosing regimen)
Time frame: Up to 24 months
Presence of target joints at enrollment and at end of prophylaxis prescription (overall and by dosing regimen)
Time frame: Up to 24 months
Damoctocog alfa pegol dose per infusion (overall and by dosing regimen)
Time frame: Up to 24 months
Number of FVIII infusions (overall and by dosing regimen)
Time frame: Up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- 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.
Related trials for Hemophilia A
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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.
12 sites in 11 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 12 sites in 11 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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States, Brazil, Canada, Colombia, Denmark and 6 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Bayer Clinical Trials Contact ((+)1-888-84 22937, clinical-trials-contact@bayer.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of treated bleeds per individual diary documentation period while prescribed damoctocog alfa pegol prophylaxis (overall and by dosing regimen) (time frame: Up to 24 months). 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 26 Oct 2026.