A Phase 3 Open-label Interventional Study of an Intravenous Recombinant Coagulation Factor VIII Fc-von Willebrand Factor-XTEN Fusion Protein BIVV001 in Patients With Severe Hemophilia A

  • STATUS
    Recruiting
  • participants needed
    150
  • sponsor
    Bioverativ, a Sanofi company
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Updated on 28 March 2023
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treatment regimen
aptt
hemophilia
coagulation factor
coagulant
severe haemophilia a
antihemophilic factor
von willebrand's disease
cryoprecipitate
von willebrand factor
emicizumab
haemophilia a

Summary

Primary Objective:

  • To evaluate the efficacy of BIVV001 as a prophylaxis treatment in prophylaxis treatment arm.

Secondary Objectives:

  • 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 the 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 efficacy of BIVV001 for perioperative management
  • To evaluate the safety and tolerability of BIVV001 treatment
  • To assess the pharmacokinetics (PK) of BIVV001 based on the 1-stage activated partial thromboplastin time (aPTT) and 2-stage chromogenic FVIII activity assays

Description

Participants in prophylaxis arm will receive a weekly prophylactic dose of BIVV001 for 52 weeks. Participants in on-demand arm will receive BIVV001 on demand for 26 weeks followed by a switch to weekly prophylaxis for another 26 weeks.

The Sponsor plans to perform a long-term safety trial. Enrollment in this open-label extension study will be offered to patients completing the treatment period based on eligibility criteria.

Details
Condition Hemophilia A, hemophilia, hemophilia
Age 12years - 100years
Treatment BIVV001
Clinical Study IdentifierNCT04161495
SponsorBioverativ, a Sanofi company
Last Modified on28 March 2023

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treatment regimen
aptt
hemophilia
coagulation factor
coagulant
severe haemophilia a
antihemophilic factor
von willebrand's disease
cryoprecipitate
von willebrand factor
emicizumab
haemophilia a

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