A Phase 2, Open-Label, Multicenter, Multi-cohort, Single-Arm Study to Investigate the Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection

Trial Profile

A Phase 2, Open-Label, Multicenter, Multi-cohort, Single-Arm Study to Investigate the Safety and Efficacy of Sofosbuvir + Ribavirin in Adolescents and Children With Genotype 2 or 3 Chronic HCV Infection

Active, no longer recruiting
Phase of Trial: Phase II

Latest Information Update: 19 Jun 2017

At a glance

  • Drugs Ribavirin (Primary) ; Sofosbuvir (Primary)
  • Indications Hepatitis C
  • Focus Adverse reactions; Pharmacokinetics; Therapeutic Use
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 13 Jun 2017 Status changed from recruiting to active, no longer recruiting.
    • 22 May 2017 Results (n=52) assessing safety and efficacy of sofosbuvir and ribavirin in adolescents with chronic hepatitis C virus-genotype 2 or 3 infection, published in the Hepatology.
    • 07 Apr 2017 According to a Gilead Sciences, based on data of this study, US FDA approved supplemental indication of sofosbuvir, in combination with ribavarin, for the treatment of Hepatitis C infections (genotype 2 or 3 HCV), without cirrhosis or with compensated cirrhosis in adolescents at least 12 years of age or weighing more than 35 kgs.
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