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

Plain-language summary

This study investigates the safety and efficacy of Sofosbuvir/Velpatasvir (SOF/VEL) in adolescents and children with chronic hepatitis C virus (HCV) infection. It enrolled children and adolescents aged 3 to under 18, both treatment-naive and previously treated. The study was carried out in Phase 2 and has been completed.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 2

Status

Completed

Sponsor

Gilead Sciences

Intervention

SOF/VEL, SOF/VEL

Start date

1/26/2017

Estimated completion

2/26/2020

Countries

United States, Belgium, Italy, United Kingdom

Related genes

Locations

• Los Angeles, United States
• San Francisco, United States
• Aurora, United States
• Washington D.C., United States
• Gainesville, United States
• Orlando, United States
• Atlanta, United States
• Indianapolis, United States
• Louisville, United States
• Baltimore, United States
• Boston, United States
• Kansas City, United States
• Omaha, United States
• New York, United States
• Cincinnati, United States
• Columbus, United States
• Philadelphia, United States
• Nashville, United States
• Fort Worth, United States
• Houston, United States
• Seattle, United States
• Brussels, Belgium
• Bologna, Italy
• Florence, Italy
• San Giovanni Rotondo, Italy
• Leeds, United Kingdom
• London, United Kingdom

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.

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.