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A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection (NCT03022981)

This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase. The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection. The primary objective of the Treatment Phase is to evaluate the safety and tolerability of SOF/VEL for 12 weeks in pediatric participants with chronic HCV.
  • Drug: SOF/VEL
    FDC tablet administered orally once daily
    • Epclusa®
    • GS-7977/GS-5816
Ages eligible for Study
3 Years to 17 Years
Genders eligible for Study
All
Accepts Healthy Volunteers
No
Inclusion Criteria:
  • Key
Exclusion Criteria:
  • Chronic HCV-infected, treatment-naive and treatment-experienced adolescent and pediatric individuals aged 3 to < 18 as determined at Day 1. Note: Other protocol defined Inclusion/Exclusion criteria may apply.

20 locations

Status:
recruiting
Type:
Interventional
Phase:
Start:
25 January, 2017
Updated:
05 July, 2017
Participants:
200
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