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Clinical trial

Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy (POLARIS-2)

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Last updated:1st Nov 2015
Identifier: NCT02607800

This study will evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) and SOF/VEL in adults with chronic HCV infection who have not previously received treatment with direct-acting antiviral 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 Compared to Sofosbuvir/Velpatasvir for 12 Weeks in Direct-Acting Antiviral-Naïve Subjects With Chronic HCV Infection
Enrollment: 943
Study Start Date: November 2015
Study Completion Date: January 2017
Primary Completion Date: October 2016 (Final data collection date for primary outcome measure)

- Experimental:
- Active Comparator: SOF/VEL 12 weeks

Category Value
Date last updated at source 2017-01-18
Study type(s) Interventional
Expected enrolment 943
Study start date 2015-11-01
Estimated primary completion date 2016-10-01

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