A Phase 3b, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection.

Trial Profile

A Phase 3b, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection.

Completed
Phase of Trial: Phase III

Latest Information Update: 24 Nov 2017

At a glance

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

    • 24 Nov 2017 Results (n=126) assessing the efficacy and safety of ledipasvir-sofosbuvir for 8 weeks in non-cirrhotic, treatment-naive, HCV mono-infected and HCV/HIV-1 co-infected patients, published in the Clinical Drug Investigation Journal.
    • 08 Oct 2017 Results of pooled analysis (n=294) describing the effectiveness of the single tablet regimen of ledipasvir/sofosbuvir using data from two prospective clinical trials (NCT02472886, NCT02480387) and four real world cohorts (German Hepatitis C-Registry,Madrid-CoRe,Veterans Health Administration,Saint Michaels), presented at the IDWeek 2017.
    • 10 Jun 2017 Biomarkers information updated
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