A Study to Learn How Safe the Study Treatment BAY94-9027 is and How it Affects the Body in Previously Treated Children Aged 7 to Less Than 12 Years With Severe Hemophilia A
21824 - A Phase 3, Single Group Treatment, Open-label, Study to Evaluate the Safety of BAY 94-9027 Infusions for Prophylaxis and Treatment of Bleeding in Previously Treated Children Aged 7 to <12 Years With Severe Hemophilia A
-
Clinical Trial Information
Trial Contact: Spinelli, Jennifer; Parker, Melanie; Armatti, Julie M; Doyle, Katherine M; Dubberly, Paige D
Trial Phone: 321.841.5357 ; 321-843-1036 ; 321-843-5284 ; 3218412008 ; 321-841-7561
-
IRB No: 22.033.02
Protocol Abbrev: 21824
Principal Investigator: Shveta Gupta, MD
Phase: Drug: Phase III
Age Group: Pediatric
Secondary Protocol No: 21824
Treatment: Biological: Damoctocog alfa pegol (Jivi, BAY94-9027)
Therapies Involved: Medication
ClinicalTrials.gov ID: NCT05147662
-
Objective
The main purpose of this study is to learn how safe BAY94-9027 is (safety) and how it affects the body (tolerability) in previously treated children with severe hemophilia A who are between 7 to less than 12 years. To answer this question, the researchers will study information about two medical problems of special interest, if allergic reactions occur (also called hypersensitivity) and if the drug is not working as well as it should (also called loss of efficacy) during the first 4 infusions.
-
Key Eligibility
Ages Eligible for Study: 7 Years to 11 Years (Child)
Sexes Eligible for Study: Male
Accepts Healthy Volunteers: No
- Participants with severe hemophilia A (participant's own FVIII activity [FVIII:C] <1%
- Participants must be previously treated with FVIII concentrate(s) (plasma derived or recombinant) for a minimum of 50 exposure days (EDs) at the time of signing the informed consent
