Safety, Efficacy and PK of BIVV001 in Pediatric Patients With Hemophilia A (XTEND-Kids)

  • STATUS
    Not Recruiting
  • End date
    Feb 1, 2023
  • participants needed
    75
  • sponsor
    Bioverativ, a Sanofi company
Updated on 13 May 2022

Summary

Primary Objective:

  • To evaluate the safety of BIVV001 in previously treated pediatric subjects with hemophilia A

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 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

Description

Study duration per participants will be approximately 60 weeks (maximum 8 weeks for screening and 52 weeks of treatment)

All participants completing or remaining at the end of study will be offered participation in the planned extension trial.

Details
Condition Hemophilia A
Treatment efanesoctocog alfa (BIVV001)
Clinical Study IdentifierNCT04759131
SponsorBioverativ, a Sanofi company
Last Modified on13 May 2022

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