A Phase 3b, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection

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Trial Profile

A Phase 3b, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection

Completed
Phase of Trial: Phase III

Latest Information Update: 16 Mar 2018

At a glance

  • Drugs Ledipasvir/sofosbuvir (Primary) ; Ribavirin; Sofosbuvir
  • Indications Hepatitis C
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 24 Oct 2017 Primary endpoint (Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)) has been met, as per results presented at The Liver Meeting 2017: 68th Annual Meeting of the American Association for the Study of Liver Diseases.
    • 24 Oct 2017 Results assessing virologic response presented at The Liver Meeting 2017: 68th Annual Meeting of the American Association for the Study of Liver Diseases.
    • 19 May 2017 Status changed from active, no longer recruiting to completed.
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