NCT04211909

Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection

A Phase 3b Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic HCV Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

Summary

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC in participants with chronic HCV infection.

Conditions

• Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	SOF/VEL	400/100 mg FDC tablet orally once daily.
DRUG	SOF/VEL/VOX	400/100/100 mg FDC tablet orally once daily.

Timeline

• Start date: 2020-01-03
• Primary completion: 2020-11-12
• Completion: 2020-11-12
• First posted: 2019-12-26
• Last updated: 2021-10-27
• Results posted: 2021-10-27

Locations

22 sites across 1 country: South Korea

Regulatory

• FDA-regulated drug study