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An Open-label, Single Arm Study, Evaluating the Immunogenicity and Safety of HEPLISAV-B in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis

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Trial Profile

An Open-label, Single Arm Study, Evaluating the Immunogenicity and Safety of HEPLISAV-B in Adults With End-Stage Renal Disease (ESRD) Undergoing Hemodialysis

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 17 Jan 2025

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At a glance

  • Drugs Adjuvanted Hepatitis-B vaccine (Recombinant)-Dynavax (Primary)
  • Indications Hepatitis B
  • Focus Adverse reactions; Pharmacodynamics
  • Sponsors Dynavax Technologies

    • Most Recent Events

    • 13 Jan 2025 According to a Dynavax Technologies media release, Dynavax received feedback from the FDA regarding the potential to conduct an observational retrospective cohort study to support its sBLA filing for adults on hemodialysis.
    • 08 Aug 2024 Status changed from active, no longer recruiting to completed.
    • 06 Aug 2024 According to a Dynavax Technologies media release, Company intends to meet with the FDA in the second half of 2024, as part of the standard post-CRL regulatory process, to discuss pathways to amend its sBLA with additional data to support the four-dose regimen for the adult hemodialysis population in the U.S.

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