NCT03343444

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Egyptian Liver Hospital · Academic / Other
• Sex: All
• Age: 12 Years – 18 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Hepatitis C Virus Infection, Response to Therapy of

Interventions

Type	Name	Description
DRUG	12 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)	Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 12 weeks
DRUG	8 weeks (Sofosbuvir 400mg/Ledipasvir 90mg)	Single Tablet (Sofosbuvir 400mg/Ledipasvir 90mg) daily for 8 weeks

Timeline

• Start date: 2017-04-15
• Primary completion: 2018-11-01
• Completion: 2019-05-31
• First posted: 2017-11-17
• Last updated: 2018-05-24

Locations

1 site across 1 country: Egypt