drugset / Trial / NCT03343444
Safety & Efficacy of Sofosbuvir 400mg/Ledipasvir 90mg in the Treatment of Chronic Hepatitis C Adolescents
RandomizedParallel-groupOpen-labelTreatment
Summary
Randomized, open-label study in treatment naïve and treatment experienced, adolescence to determine the efficacy of Sofosbuvir 400mg/ledipasvir 90mg in treatment naïve and treatment-experienced adolescence. Hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (SVR12)
Timeline
- Start
- 2017-04-15
- Primary completion
- 2018-11-01
- Completion
- 2019-05-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Ledipasvir | Small molecule | 90 mg | Oral |
| Comparator | Sofosbuvir | Small molecule | 400 mg | Oral |