Status and phase
Conditions
Treatments
Study type
Funder types
Identifiers
About
This study is for young children with severe hemophilia A who have previously not been treated with BAX855 or other FVIII concentrates.
The main aim of the study is to check for side effects from treatment with BAX855. This includes the buildup of antibodies against FVIII which may stop BAX855 from working properly. Another aim is to learn how well BAX855 controls bleeding.
In this study, the children can receive BAX855 either as preventative treatment (prophylaxis), or as needed to treat bleeding (on-demand).
In case a participant develops antibodies, treatment will be provided as part of the study.
Enrollment
Sex
Ages
Volunteers
Inclusion and exclusion criteria
Inclusion Criteria
Additional inclusion criteria for Part B (immune tolerance induction [ITI]).
Parent or legal representative has/have voluntarily provided signed informed consent for ITI portion.
Participant has a confirmed positive high titer inhibitor (> 5.00 Bethesda unit (BU)) or has a positive confirmed low titer inhibitor (greater than or equal to [>=] 0.6 BU) as determined by the central laboratory based on a second repeat blood sample with
Exclusion Criteria
Additional exclusion criteria for Part B (ITI)
Primary purpose
Allocation
Interventional model
Masking
120 participants in 1 patient group
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Data sourced from clinicaltrials.gov
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