Trials / Terminated
TerminatedNCT03820258
Study to Investigate Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX) Fixed Dose Combination (FDC) in Adolescents and Children With Chronic Hepatitis C Virus (HCV) Infection
A Phase 2, Open-Label, Multicenter, Multi-cohort Study to Investigate the Pharmacokinetics, Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed Dose Combination in Adolescents and Children With Chronic HCV Infection
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 21 (actual)
- Sponsor
- Gilead Sciences · Industry
- Sex
- All
- Age
- 3 Years – 17 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of this study is to evaluate the steady-state pharmacokinetics (PK) and confirm the age-appropriate dose of sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection.
Detailed description
Participants will receive placebo to match SOF/VEL/VOX FDC to assess ability to swallow tablets at screening up to Day 1.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SOF/VEL/VOX | Administered once daily with food. |
Timeline
- Start date
- 2019-01-28
- Primary completion
- 2019-12-04
- Completion
- 2020-02-19
- First posted
- 2019-01-29
- Last updated
- 2020-10-23
- Results posted
- 2020-08-31
Locations
10 sites across 3 countries: Italy, Poland, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03820258. Inclusion in this directory is not an endorsement.