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

Trial Profile

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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 01 Aug 2016

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At a glance

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

    • 24 Dec 2015 Pooled data analysis results from ION-1, ION-2, ION-3 and GS-US337-0113 in genotype 1 HCV infected patients, published in the Hepatology
    • 03 Jul 2015 The Japanese MHLW approved Harvoni (ledipasvir 90mg/sofosbuvir 400mg) for the treatment of chronic hepatitis C virus genotype 1 infection in adults, according to a Gilead Sciences media release.
    • 01 Jun 2015 Results published in The Lancet Infectious Diseases.
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