Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Bioverativ, a Sanofi company
Duration of each part of the study for one participant:
Total study duration: Up to 57 days.
* Screening: up to 28 days.
* Up to 29 days of safety observation following the IV BIVV001 dose administration (this period includes PK sampling up to the first 10 days following administration).
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
\-- Male and/or female participant, between 18 and 65 years of age, inclusive at the time of informed consent.
The participant has been diagnosed with hereditary type 3 VWD or type 2N VWD as documented in historical medical records OR a documented genotype known to produce VWD type 3 or 2N VWD.
Type 3 VWD participants are included if they have a medical history of at least 25 exposure days to VWF and factor VIII-containing coagulation factor concentrates
Type 2N VWD participants are included if the use of DDAVP is deemed insufficient or contraindicated, as assessed by the Investigator, or if they have required prior use of VWF- and FVIII- containing coagulation factor concentrates.
You may not be if
Hereditary or acquired coagulation disorder other than VWD (including qualitative and quantitative platelet disorders, and thrombocytopenia \< 100,000 cells/uL at Screening)
The participant has a FVIII activity levels \>20 IU/dL, at Screening
History or presence of a VWF inhibitor or clinical suspicion of a VWF inhibitor
History of a positive FVIII inhibitor test, defined as ≥0.6 BU/mL (by Nijmegen modified Bethesda assay) or a clinical suspicion of a FVIII inhibitor
Positive FVIII inhibitor test, defined as ≥0.6 BU/mL, at Screening
History of hypersensitivity or anaphylaxis associated with any FVIII- or VWF- containing product
The participant has received or anticipates receiving systemic immunosuppressive or immunomodulatory treatment within 12 weeks prior to Baseline.
The participant requires the use of acetylsalicylic acid, non-NSAID anti-platelets, and NSAIDs above the maximum dose product
Patients currently on a prophylaxis regimen for the treatment of VWD that, in the Investigator's opinion, would preclude participation in the study due to the possible increased risk of bleeding associated with the requirement to withhold prophylaxis during the study.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Clareo Health | To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD)
