To evaluate the long-term safety of BIVV001 in previously treated subjects with hemophilia
To evaluate the efficacy of BIVV001 as a prophylaxis treatment.
To evaluate the efficacy of BIVV001 in the treatment of bleeding episodes.
To evaluate BIVV001 consumption for prevention and treatment of bleeding episodes.
To evaluate the effect of BIVV001 prophylaxis on joint health outcomes.
To evaluate the effect of BIVV001 prophylaxis on Quality of Life (QoL) outcomes.
To evaluate the safety and tolerability of BIVV001 treatment.
To assess the PK of BIVV001 based on the one stage activated partial thromboplastin time
(aPTT) and two-stage chromogenic FVIII activity assays (only applicable to Arm B).
To evaluate the efficacy of BIVV001 for perioperative management
Participants will receive BIVV001 once weekly for a total of at least 100 exposure days to
BIVV001 (including exposure during a BIVV001 parent study, if applicable). Participants will
have the opportunity to continue in this study for up to 4 years, unless BIVV001 is
commercially available in their applicable participating country.
If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.
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