This site is intended for healthcare professionals
Clinical trials
  • Home
  • /
  • Clinical trials
  • /
  • Vosevi
  • /
  • Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks...
Clinical trial

Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis

Read time: 3 mins
Last updated:1st Nov 2015
Identifier: NCT02639338

This study will evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in adults with chronic genotype 3 hepatitis C virus (HCV) infection and cirrhosis who have not previously received treatment with direct-acting antiviral (DAA) therapy.


Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Global, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 8 Weeks and Sofosbuvir/Velpatasvir for 12 Weeks in Subjects With Chronic Genotype 3 HCV Infection and Cirrhosis
Enrollment: 220
Study Start Date: December 2015
Study Completion Date: January 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

Arms:
- Experimental:
SOF/VEL/VOX
- Experimental: SOF/VEL

Category Value
Date last updated at source 2017-01-13
Study type(s) Interventional
Expected enrolment 220
Study start date 2015-11-01
Estimated primary completion date 2016-10-01

View full details