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A Phase 3b, Multicenter, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin (± Pegylated Interferon) in Subjects With Chronic Genotype 1, 2, 3 and 6 HCV Infection

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Trial Profile

A Phase 3b, Multicenter, Open-Label, Randomized Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin (± Pegylated Interferon) in Subjects With Chronic Genotype 1, 2, 3 and 6 HCV Infection

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 14 Jan 2020

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At a glance

  • Drugs Sofosbuvir (Primary) ; Peginterferon alfa-2a; Ribavirin
  • Indications Hepatitis C
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Sponsors Gilead Sciences

    • Most Recent Events

    • 13 Nov 2018 Results (n=126) comparing the efficacy of sofosbuvir (SOF) plus ribavirin (RBV) in Chinese patients with GT3a and GT3b HCV infection, presented at The Liver Meeting 2018: 69th Annual Meeting of the American Association for the Study of Liver Diseases.
    • 25 Sep 2017 According to a Gilead Sciences media release, the China Food and Drug Administration (CFDA) has approved Sovaldi (sofosbuvir 400mg), a once-daily oral nucleotide analog polymerase inhibitor for the treatment of chronic hepatitis C virus (HCV) infection.
    • 16 Nov 2016 Status changed from active, no longer recruiting to completed.
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