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Not Yet Recruiting 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07088458). StuddyBuddy aggregates publicly available trial information.