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A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/-Ribavirin Adolescents and Children With Chronic HCV-Infection

Trial Profile

A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed Dose Combination +/-Ribavirin Adolescents and Children With Chronic HCV-Infection

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 20 Jun 2019

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At a glance

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

    • 20 Jun 2019 Results (n=34) assessing efficacy and tolerability of Ledipasvir-sofosbuvir in 3 to <6 years old patients with chronic hepatitis C infection, published in the Hepatology.
    • 13 Nov 2018 Results (n=34) assessing the safety and efficacy of treatment with LDV/SOF FDC in HCV- infected children 3 to <6 years old, presented at The Liver Meeting 2018: 69th Annual Meeting of the American Association for the Study of Liver Diseases.
    • 31 Aug 2018 Status changed from active, no longer recruiting to completed.
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