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A Phase I, Randomized, Double-blind, Placebo-controlled, Multi-centre, Ascending-dose Trial to Evaluate the Safety, Tolerability and Immunogenicity of Vaccine FP-02.2 in HBeAg-negative Hepatitis B Patients as an add-on Treatment to Entecavir or Tenofovir.

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Trial Profile

A Phase I, Randomized, Double-blind, Placebo-controlled, Multi-centre, Ascending-dose Trial to Evaluate the Safety, Tolerability and Immunogenicity of Vaccine FP-02.2 in HBeAg-negative Hepatitis B Patients as an add-on Treatment to Entecavir or Tenofovir.

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 06 Nov 2021

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At a glance

  • Drugs FP 02.2 (Primary) ; IC 31
  • Indications Hepatitis B
  • Focus Adverse reactions; First in man
  • Sponsors Altimmune; Eli Lilly and Company

    • Most Recent Events

    • 29 Jan 2019 According to an Altimmune media release, this study met its primary endpoint of safety and showed that HepTcell treatment was associated with increased HBV-specific cellular immune responses.
    • 29 Jan 2019 According to an Altimmune media release, results will be presented on April 12, 2019 at The International Liver Congress sponsored by The European Association for the Study of the Liver (EASL).
    • 08 Jan 2019 Status changed from active, no longer recruiting to completed.
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