NCT04112303

Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination for 12 Weeks in Adults With Chronic HCV Infection and Compensated Cirrhosis

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

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 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) in adults with chronic hepatitis C virus (HCV) infection and compensated cirrhosis.

Conditions

• Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	SOF/VEL	Tablets administered orally once daily

Timeline

• Start date: 2019-10-16
• Primary completion: 2021-03-26
• Completion: 2021-06-25
• First posted: 2019-10-02
• Last updated: 2022-04-20
• Results posted: 2022-04-20

Locations

22 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study