Overview

Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection

Status:
Completed

Trial end date:
2020-02-26

Target enrollment:

Participant gender:

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.

Phase:

Phase 2

Details

Lead Sponsor:

Gilead Sciences

Treatments:

Sofosbuvir
Sofosbuvir-velpatasvir drug combination
Velpatasvir