drugset / Trial / NCT03022981
Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection
Non-randomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-01-26
- Primary completion
- 2019-11-19
- Completion
- 2020-02-26
Publications
- Results Jonas MM, Romero R, Sokal EM, Rosenthal P, Verucchi G, Lin CH, et al. The Safety and Efficacy of Sofosbuvir/Velpatasvir in Pediatric Patients 6 to < 18 years old with Chronic Hepatitis C Infection [Abstract]. AASLD; 2019 08-12 November; Boston, Massachusetts.
- Jonas MM, Romero R, Rosenthal P, Lin CH, Verucchi G, Wen J, Balistreri WF, Whitworth S, Bansal S, Leung DH, Narkewicz MR, Gonzalez-Peralta RP, Mangia A, Karnsakul W, Rao GS, Shao J, de Jong J, Parhy B, Osinusi A, Kersey K, Murray KF, Sokal EM, Schwarz KB. Sofosbuvir-velpatasvir in children 3-17 years old with hepatitis C virus infection. J Pediatr Gastroenterol Nutr. 2024 Jun;78(6):1342-1354. doi: 10.1002/jpn3.12045. Epub 2024 Apr 21.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sofosbuvir | Small molecule | 150 mg | Oral |
| Subject | Sofosbuvir | Small molecule | 200 mg | Oral |
| Subject | Sofosbuvir | Small molecule | 400 mg | Oral |
| Subject | velpatasvir | Other / unclassified | 37.5 mg | Oral |
| Subject | velpatasvir | Other / unclassified | 50 mg | Oral |
| Subject | velpatasvir | Other / unclassified | 100 mg | Oral |