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A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Negative, Chronic Hepatitis B

Trial Profile

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Negative, Chronic Hepatitis B

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Jul 2019

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At a glance

  • Drugs Tenofovir alafenamide (Primary) ; Tenofovir disoproxil fumarate
  • Indications Hepatitis B
  • Focus Registrational; Therapeutic Use
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 18 Nov 2018 According to a Gilead Sciences media release, based on the data from this (Study 108) and other phase III study (Study 110), the China NMPA has approved Vemlidy 25 mg, a once-daily treatment for chronic hepatitis B in adults and adolescents (aged 12 years and older with body weight at least 35 kg).This is the first treatment approved for HBV in ten years which offers improved renal and bone laboratory safety parameters compared to tenofovir disoproxil fumarate.
    • 13 Nov 2018 Results presented at The Liver Meeting 2018: 69th Annual Meeting of the American Association for the Study of Liver Diseases
    • 13 Nov 2018 Results presented at The Liver Meeting 2018: 69th Annual Meeting of the American Association for the Study of Liver Diseases
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