Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection
Completed · Phase 2
Conditions studied: Hepatitis C Virus Infection
In brief
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.
Key facts
- Study ID
- NCT03022981
- Run by
- Gilead Sciences
- People needed
- 216
- Starts
- 2017-01-26
- Expected to finish
- 2020-02-26
- Last updated by the study team
- 2020-10-08
Who can join
Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Children's Hospital & Medical Center — Omaha, Nebraska, United States
- Mount Sinai Medical Center — New York, New York, United States
- Cincinnati Children's Hospital Medical Center — Cincinnati, Ohio, United States
- Nationwide Children's Hospital- The Ohio State University (OSU) — Columbus, Ohio, United States
- The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States
- Monroe Carell Jr. Children's Hospital at Vanderbilt — Nashville, Tennessee, United States
- Cook Children's Medical Center — Fort Worth, Texas, United States
- Baylor College of Medicine — Houston, Texas, United States
- Seattle Children's Hospital — Seattle, Washington, United States
- Cliniques Universitaires Saint Luc — Brussels, Belgium
- Azienda Ospedaliero-Universitaria di Bologna - Policlinico S. Orsola - Malpighi — Bologna, Italy
- Azienda Ospedaliera Universitaria Meyer — Florence, Italy
- Ospedale Casa Sollievo della Sofferenza — San Giovanni Rotondo, Italy
- The Leeds Teaching Hospitals NHS Trust — Leeds, England, United Kingdom
- King's College Hospital NHS Trust — London, England, United Kingdom
- Children's Hospital Los Angeles — Los Angeles, California, United States
- University of California, San Francisco — San Francisco, California, United States
- Children's Hospital of Colorado — Aurora, Colorado, United States
- Children's National Medical Center — Washington D.C., District of Columbia, United States
- University of Florida Shands Medical — Gainesville, Florida, United States
- Florida Gastroenterology Care for Children — Orlando, Florida, United States
- Emory Children's Center — Atlanta, Georgia, United States
- Riley Hospital for Children — Indianapolis, Indiana, United States
- Kosair Charities Pediatric Clinical Research Unit — Louisville, Kentucky, United States
- Johns Hopkins University (JHU) - The Johns Hopkins Hospital (JHH) — Baltimore, Maryland, United States
Full record on ClinicalTrials.gov
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