To Assess the Pharmacokinetics and Safety and Tolerability of Efanesoctocog Alfa (BIVV001)in Adults With Type 2N and 3 Von Willebrand Disease (VWD)

  • STATUS
    Recruiting
  • days left to enroll
    65
  • participants needed
    9
  • sponsor
    Bioverativ, a Sanofi company
Send
Updated on 4 October 2022
See if I qualify
aptt
Factor VIII
coagulation factor
bleeding tendency
antihemophilic factor
coagulation studies
ddavp
type 3 vwd

Summary

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

Description

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).

Details
Condition Von Willebrand's Disease (VWD)
Treatment efanesoctocog alfa (BIVV001)
Clinical Study IdentifierNCT04770935
SponsorBioverativ, a Sanofi company
Last Modified on4 October 2022

Eligibility

 Yes No Not Sure

Inclusion Criteria

- 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

Exclusion Criteria

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
Hereditary or acquired coagulation disorder other than VWD (including qualitative and
quantitative platelet disorders, and thrombocytopenia < 100,000 cells/uL at Screening)
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
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

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.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

aptt
Factor VIII
coagulation factor
bleeding tendency
antihemophilic factor
coagulation studies
ddavp
type 3 vwd

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name
Edit Delete

Added by • 

 • 

Private

Edit Delete

Reply by • • Private
Edit Delete

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note