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-Positive, 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-Positive, Chronic Hepatitis B

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 19 Sep 2017

At a glance

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

    • 19 Jun 2017 According to a Gilead Sciences media release, based on the data from this and other study (study 108), Health Canada has approved VEMLIDY (tenofovir alafenamide, TAF) 25mg tablets, a once-daily treatment for adults with chronic hepatitis B virus (HBV) infection with compensated liver disease.
    • 09 May 2017 Results of 96 week efficacy and safety were presented at the Digestive Disease Week 2017.
    • 20 Apr 2017 According to a Gilead Sciences media release, 96-week results from this trial were presented at The International Liver Congress 2017.
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