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A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Japanese Subjects With Chronic Genotype 2 HCV Infection

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Trial Profile

A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir Plus Ribavirin in Treatment-Naive and Treatment-Experienced Japanese Subjects With Chronic Genotype 2 HCV Infection

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 09 Mar 2016

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At a glance

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

    • Most Recent Events

    • 30 Apr 2015 According to Gilead Sciences media release Sovaldi (Sofosbuvir) was approved by Japanese Ministry of Health, labour and Welfare for suppression of viremia in patients with genotype 2 chronic HCV infection with or without compensated cirrhosis.
    • 26 Mar 2015 According to a Chugai Pharmaceuticals media release, based on the results of this trial ribavirin (Copegus) has obtained approval for an additional indication for "improvement of viraemia associated with chronic hepatitis C (CHC) and compensated cirrhosis related to hepatitis C".
    • 26 Mar 2015 Results published in a Chugai Pharmaceuticals media release.

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