Trial Profile
A Phase 3b, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of Ledipasvir/Sofosbuvir in Adults With Chronic HCV Infection.
Status:
Completed
Phase of Trial:
Phase III
Latest Information Update: 06 Nov 2021
Price :
$35
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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.
- 05 Jul 2016 Status changed from active, no longer recruiting to completed.