A Phase 3b, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection.
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
- 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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Table of Contents
- At a glance
- Trial Overview
- Trial Details
- Trial Centres
- Trial History