Summary

for people ages 3-17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:
Philip Rosenthal

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 Infection Communicable Diseases Hepatitis C Virus Diseases Sofosbuvir Sofosbuvir-velpatasvir drug combination SOF/VEL

Eligibility

For people ages 3-17

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

  • University of California, San Francisco accepting new patients
    San Francisco California 94158 United States
  • Children's Hospital Los Angeles accepting new patients
    Los Angeles California 90027 United States

Lead Scientist

Details

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