Primary Objective: -To characterize the pharmacokinetics (PK) of BIVV001 after a single intravenous (IV) administration, as assessed by factor VIII (FVIII) activity determined by the one-stage activated partial thromboplastin time (aPPT) clotting assay, as well as, BIVV001 capture chromogenic Coatest FVIII activity assay Secondary Objective: -To assess the safety and tolerability of a single IV dose of BIVV001 in adult patients with type 2N and 3 VWD
Age range
18 Years – 65 Years
Sex
ALL
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Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
Pharmacokinetic Parameter: Maximum plasma concentration observed (Cmax)
Timeframe: Day 1 to Day 10
Pharmacokinetic Parameter: Terminal half-life (t½z)
Timeframe: Day 1 to Day 10
Pharmacokinetic Parameter: Total Clearance (CL)
Timeframe: Day 1 to Day 10
Pharmacokinetic Parameter: Volume of distribution at steady state (Vss)
Timeframe: Day 1 to Day 10
Pharmacokinetic Parameter: Area under the activity time curve extrapolated to infinity (AUC∞)
Timeframe: Day 1 to Day 10
Pharmacokinetic Parameter: Mean residence time (MRT)
Timeframe: Day 1 to Day 10
Pharmacokinetic Parameter: Incremental recovery (IR)
Timeframe: Day 1 to Day 10