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A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Korean and Taiwanese Subjects With Chronic Genotype 1 HCV Infection

Trial Profile

A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Korean and Taiwanese Subjects With Chronic Genotype 1 HCV Infection

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Feb 2019

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At a glance

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

    • 04 Dec 2018 Results presented in the Gilead Sciences media release.
    • 04 Dec 2018 According to a Gilead Sciences media release, the National Medical Products Administration(NMPA) has approved Harvoni (ledipasvir 90 mg/sofosbuvir 400 mg) in China for the treatment of chronic hepatitis C virus (HCV) genotype 1-6 infection in adults and adolescents aged 12 to 18 years, based on the results of this trial.
    • 24 Oct 2017 Results assessing the safety and efficacy of Ledipasvir/Sofosbuvir in a Genotype 1 HCV Infected Chinese Population (n=206) presented at The Liver Meeting 2017: 68th Annual Meeting of the American Association for the Study of Liver Diseases
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