drugset / Trial / NCT03343444

Safety & Efficacy of Sofosbuvir 400mg/Ledipasvir 90mg in the Treatment of Chronic Hepatitis C Adolescents

NCT03343444

Phase 3 Unknown 80 enrolled Egyptian Liver Hospital
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

EvaluationDrugModalityDoseRoute
Comparator Ledipasvir Small molecule 90 mg Oral
Comparator Sofosbuvir Small molecule 400 mg Oral