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A Randomized, Open-Label, Parallel, Multi-Center, Non-inferiority, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Switching to Besifovir Dipivoxil Maleate From Tenofovir Disoproxil Fumarate (TDF) in Chronic Hepatitis B Patients Who Pretreated With TDF

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Trial Profile

A Randomized, Open-Label, Parallel, Multi-Center, Non-inferiority, Phase IV Clinical Trial to Evaluate the Efficacy and Safety of Switching to Besifovir Dipivoxil Maleate From Tenofovir Disoproxil Fumarate (TDF) in Chronic Hepatitis B Patients Who Pretreated With TDF

Status: Completed
Phase of Trial: Phase IV

Latest Information Update: 18 Aug 2023

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At a glance

  • Drugs Besifovir (Primary) ; Tenofovir disoproxil fumarate
  • Indications Hepatitis B
  • Focus Therapeutic Use
  • Sponsors Ildong Pharmaceutical

Most Recent Events

  • 18 Aug 2023 Status changed from recruiting to completed.
  • 24 Jun 2023 Results (n=101) assessing longer-term efficacy as well as bone and renal safety in CHB patients in the extended follow-up of the study at 96 weeks presented at the European Association for the Study of the Liver Congress 2023
  • 15 Nov 2021 Primary endpoint has been met (The rate of subjects who maintained hepatitis B virus (HBV) DNA less than 20 IU/mL at the 48th week)Results presented at The Liver Meeting 2021: 72nd Annual Meeting of the American Association for the Study of Liver Diseases

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