A Phase 3b, Randomized, Double-Blind, Double-Dummy Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine Plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects With Chronic Hepatitis B Who Are Resistant to Lamivudine

Trial Profile

A Phase 3b, Randomized, Double-Blind, Double-Dummy Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine Plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects With Chronic Hepatitis B Who Are Resistant to Lamivudine

Completed
Phase of Trial: Phase III

Latest Information Update: 05 Oct 2016

At a glance

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

    • 18 Aug 2016 Results at week 240 follow-up published in the Journal of Hepatology
    • 05 Mar 2015 Status changed from active, no longer recruiting to completed, as reported by ClinicalTrials.gov
    • 02 Oct 2014 Planned End Date changed from 1 Aug 2014 to 1 Feb 2015 as reported by ClinicalTrials.gov record.
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