Phase IV Study
Real World Prospective
PTPs 7 to <12 Years
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The clinical trials presented may include uses or patient populations that have not been approved by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), or other health authorities. This information is presented only for purposes of providing a general overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved uses.
Bayer and the Bayer Cross are registered trademarks of Bayer. © Oct
2025 Bayer. All rights reserved.
MA-M_DAM-US-0200-1
Study of Damoctocog Alfa Pegol in Children 7 to <12 years old
Kids
An Observational Study Describing Real-World Treatment Outcomes with Damoctocog Alfa Pegol in Previously Treated Patients Aged 7 to <12 Years With Hemophilia A
Study aim is to describe the treatment outcomes during prescription of regular continuous prophylaxis with damoctocog alfa pegol in a real-world setting
Patient population: previously treated patients of any disease severity and gender with hemophilia A, aged 7 to <12 years at enrollment and initiating or receiving damoctocog alfa pegol as their primary form of bleeding prophylaxis
Estimated enrollment: 30-40 patients
Estimated timeline
Purpose
To describe the treatment outcomes of damoctocog alfa pegol prophylaxis in a real-world setting in previously treated patients aged 7 to <12 years
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Objectives
Inclusion & exclusion criteria
ClinicalTrials.gov identifier: NCT07088458
Bayer and the Bayer Cross are registered trademarks of Bayer. © Oct
2025 Bayer. All rights reserved.
The clinical trials presented may include uses or patient populations that have not been approved by the US Food and Drug Administration (FDA), European Medicines Agency (EMA), or other health authorities. This information is presented only for purposes of providing a general overview of clinical trials and should not be construed as a recommendation for use of any product for unapproved uses.
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Primary objective
- Assess the treatment outcomes during prescription of regular continuous prophylaxis with damoctocog alfa pegol in the real-world setting, following approved local label or any other regular prophylaxis regimen prescribed by the physician as part of normal clinical practice
Secondary objective
- Describe treatment outcomes based on bleed occurrence during 6-month intervals
- Describe target joints at enrollment and during study
- Describe utilization of damoctocog alfa pegol and other FVIII medications
- Describe hemostasis during perioperative period for major and minor surgeries
- Measure joint health at enrollment and during study
- Measure patients’ quality of life and self-perceived functional abilities at enrollment and during the study
- Describe PK parameters
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Inclusion criteria*
- 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 evidencea of FVIII inhibitor or clinical suspicionb 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
Exclusion criteria
- 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 or intention to use another hemostatic agent as the primary method of bleeding prophylaxis
- Contraindications according to the local marketing authorization
- Current immune tolerance induction treatment for a FVIII inhibitor
aEvidence of FVIII inhibitor as measured by the Nijmegen-modified Bethesda assay (≥0.6 BU/mL) or Bethesda assay (≥1.0 BU/mL) in 2 consecutive samples. bDocumented or clinical suspicion of shortened FVIII half-life (<6 hours).
*The above are a summary of select inclusion and exclusion criteria. Please see clinicaltrials.gov posting for complete inclusion/exclusion criteria.
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