CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 216 enrolled
Drug / intervention
SOF/VEL +1 moredrug
Likely dose
SOF/VEL 100 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03022981
NCT03022981Phase 2Completed
CompareCT.gov

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

Gilead Sciences·interventional·Posted Jan 18, 2017·Updated Oct 8, 2020

In Brief

A Phase 2 clinical trial evaluating SOF/VEL for Hepatitis C Virus Infection. Completed, enrolled 216 participants across 27 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis C Virus Infection
CountriesBelgium, Italy, United Kingdom, United States
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedJan 18, 2017
Enrollment StartJan 26, 2017
Primary CompletionNov 19, 2019
Study CompletionFeb 26, 2020
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 9.5 years ago

Interventions

SOF/VELdrug

SOF/VEL fixed-dose combination (FDC) 400/100 mg tablets or SOF/VEL FDC 200/50 mg tablets (based on swallowability assessment)

SOF/VELdrug

SOF/VEL FDC 200/50 mg oral granules