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, a Genetic Bleeding Disorder That is Caused by the Lack of a Protein Called Clotting Factor 8 (FVIII) in the Blood
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bayer
Age
7–11
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
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
Participant has understood the study if appropriate for his age, informed consent must be signed by the parent, the participant can only sign the assent
Willingness and ability of participants and/or parents /caregivers to complete training in the use of the electronic patient diary (EPD) and to document infusions during the study
You may not be if
History of FVIII inhibitors
Current evidence of inhibitor to FVIII measured using the Nijmegen-modified Bethesda assay (≥0.6 BU/mL) at the time of screening (central laboratory)
Any other inherited or acquired bleeding disorder in addition to hemophilia A (e.g. von Willebrand disease, hemophilia B)
Known hypersensitivity or allergic reaction to drug substance, excipients or mouse or hamster protein
Any other significant medical condition that the investigator feels would be a risk to the patient or would impede the study
Requires any pre-medication to tolerate FVIII treatment (e.g. antihistamines)
Planned major surgery during the study
Any individual who is receiving chemotherapy, immune modulatory drugs other than anti-retroviral chemotherapy, or chronic use of oral or intravenous (IV) corticosteroids (\> 14 days) within the last 3 months
Any individual who received commercially available subcutaneous factor substitution therapy (emicizumab) within the last 6 months
The participant is currently participating in another investigational drug study or has participated in a clinical study involving an investigational drug within 30 days of study entry or previous participation in a clinical study with BAY94-9027
Clareo Health | 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, a Genetic Bleeding Disorder That is Caused by the Lack of a Protein Called Clotting Factor 8 (FVIII) in the Blood
