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A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant

Trial Profile

A Phase 2, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Ledipasvir Fixed-Dose Combination + Ribavirin Administered in Subjects Infected With Chronic HCV Who Have Advanced Liver Disease or Are Post-Liver Transplant

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 18 Nov 2018

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At a glance

  • Drugs Ledipasvir/sofosbuvir (Primary) ; Ribavirin
  • Indications Hepatitis C
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms SOLAR-1
  • Sponsors Gilead Sciences
  • Most Recent Events

    • 14 Apr 2018 Results assessing survival benefits of sofosbuvir-based DAA regimens in four studies (GS-US334-0125, SOLAR-1, -2 and ASTRAL-4; n=492) presented at The International Liver Congress 2018
    • 10 Mar 2018 Results of integrated retrospective analysis of SOLAR-1, SOLAR-2, ASTRAL-4, and GS-US-334-0125 trials identifying predictive factors for treatment benefits and adverse events published in the Gastroenterology
    • 24 Oct 2017 Results of pooled analysis of SOLAR-1, SOLAR-2, ASTRAL-4 and GS-US-334-0125 trials assessing predictive features of clinical improvement or deterioration presented at The Liver Meeting 2017: 68th Annual Meeting of the American Association for the Study of Liver Diseases
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