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NCT07088458
An Observational Study to Learn More About How Well Damoctocog Alfa Pegol Works in Previously Treated Children With Hemophilia A
Conditions: Hemophilia A
Sex: All
Ages: 7 Years – 12 Years
Healthy volunteers: No
Enrollment: 40
Sponsor: Bayer
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 \
Eligibility Criteria
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 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.
Exclusion Criteria:
* 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
Source: ClinicalTrials.gov (NCT07088458). StuddyBuddy aggregates publicly available trial information.