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Eligibility
for people ages 3 years to 17 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:

Description

Summary

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.

Official Title

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

Keywords

Hepatitis C Virus Infection Sofosbuvir

Eligibility

For people ages 3 years to 17 years

Key Inclusion 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.

Locations

  • Children's Hospital Los Angeles not yet accepting patients
    Los Angeles, California, 90027, USA

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT03022981
Phase
Phase 2
Study Type
Interventional
Last Updated
March 2017
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