HEM-POWR KidsNCT07088458

An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Children With Hemophilia A

StatusRecruiting

PhaseNot specified

SponsorBayer

Primary completionDec 31, 2029 (estimated)

Track this trial

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Record History

All 16 versions: 12 with changes below, 4 re-verified with no change. See every version on ClinicalTrials.gov ↗

Notable Nov 10, 2026 Eligibility criteria expanded, about 36 words
- Trial arms changed: 1 → 2
- Site details revised at 1 of 12 sites
- Study title shortened, about 2 words
Notable Oct 23, 2026 Recruitment opened Show 4 more changesShow less
- Eligibility criteria expanded, about 13 words
- Trial sites expanded: 0 → 12 locations
- Start date changed from estimate of Jun 30, 2026 to Jul 16, 2026
- Secondary endpoints: details revised at 1 of 6 entries
Minor Jun 25, 2026 Start date: Jun 18, 2026 to Jun 30, 2026v14
Minor Jun 5, 2026 Start date: May 29, 2026 to Jun 18, 2026v13
Minor May 8, 2026 Start date: Apr 30, 2026 to May 29, 2026v12

Show 6 earlier versionsHide 6 earlier versions

Minor Mar 18, 2026 Start date: Apr 5, 2026 to Apr 30, 2026v10
Notable Jan 5, 2026 Start date: Dec 15, 2025 to Apr 5, 2026v7
Notable Dec 11, 2025 Start date: Nov 1, 2025 to Dec 15, 2025
- Primary completion date: Oct 1, 2029 to Dec 31, 2029
- Study completion date: Jan 1, 2030 to Mar 1, 2030
v6
Notable Sep 26, 2025 Start date: Oct 1, 2025 to Nov 1, 2025v4
Minor Sep 1, 2025 Primary completion date: Jan 1, 2030 to Oct 1, 2029v3
Notable Aug 5, 2025 Start date: Aug 1, 2025 to Oct 1, 2025
- Primary and study completion dates pushed to Jan 1, 2030
v2

Jul 21, 2025 Study First Submitted

Notable: the plan changed
Minor: routine updates

Endpoints

Primary

Number of treated bleeds per individual diary documentation period while prescribed damoctocog alfa pegol prophylaxis (overall and by dosing regimen)

Timeframe: Up to 24 months

Secondary (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)

Occurrence of bleeds during individual diary documentation period while prescribed damoctocog alfa pegol prophylaxis prescription (overall and by dosing regimen)

Occurrence of bleeds within 6 months' time intervals including the first and the last 6 months during observation period (overall and by dosing regimen)

Presence of target joints at enrollment and at end of prophylaxis prescription (overall and by dosing regimen)

Damoctocog alfa pegol dose per infusion (overall and by dosing regimen)

Show 1 moreShow less

Number of FVIII infusions (overall and by dosing regimen)

Arms and interventions

Previously treated patients (PTPs) with hemophilia A

Previously treated patients with hemophilia A who have been prescribed damoctocog alfa pegol for regular continuous prophylaxis.

Previously untreated or minimally treated patients (PUPs/MTPs) with hemophilia A

Patients previously not treated with FVIII (previously untreated patients (PUPs)), or minimally treated (≤4 exposure days (MTPs)).

Drugs: Damoctocog alfa pegol (Jivi, Bay94-9027)

Sites

12 sites in 11 countries

United States 2, Brazil 1, Canada 1, Colombia 1, Denmark 1, Italy 1, Japan 1, Lithuania 1, Mexico 1, Norway 1, Spain 1

About this trial

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 starting or already receiving damoctocog alfa pegol as prescribed by their doctor. Participants taking part may have received factor 8 (FVIII) treatment before. The study may also include participants who have never received factor 8 treatment or who have received it only a few times. 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 (PedHAL) to assess the effect of hemophilia on their child's functional and physical activities. In this study, only available data from routine care will be collected. No additional visits or tests are required as part of this study.

Trial details

Enrollment: 40 participants (estimated)
Started: Jul 16, 2026
Study completion: Mar 1, 2030 (estimated)
Eligibility: 7 to 12, all sexes, no healthy volunteers
Design: Observational
Oversight: No data monitoring committee
Conditions: Hemophilia A
Official title: An Observational Study Describing Real-World Treatment Outcomes of Damoctocog Alfa Pegol in Patients Aged 7 to <12 Years With Hemophilia A
First posted: Jul 28, 2025
Registry updated: Nov 13, 2026
Last verified: Nov 2026

Related trials at risk

View on ClinicalTrials.gov ↗