A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks With Ribavirin or for 24 Weeks Without Ribavirin in Treatment-Experienced Cirrhotic Subjects With Chronic Genotype 1 HCV Infection

Trial Profile

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination for 12 Weeks With Ribavirin or for 24 Weeks Without Ribavirin in Treatment-Experienced Cirrhotic Subjects With Chronic Genotype 1 HCV Infection

Completed
Phase of Trial: Phase II

Latest Information Update: 07 Jul 2016

At a glance

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

    • 12 Nov 2015 According to Gilead Sciences media release, results were published in the Media Release.
    • 12 Nov 2015 According to Gilead Sciences media release, U.S. Food and Drug Administration (FDA) approved Harvoni (ledipasvir/sofosbuvir) plus ribavirin (RBV) for 12 weeks or Harvoni without (RBV) for 24 weeks in genotype 1 HCV-infected patients with compensated cirrhosis who failed prior therapy.
    • 19 Nov 2014 Status changed from active, no longer recruiting to completed as reported by ClinicalTrials.gov.
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