Overview

This trial is active, not recruiting.

Condition hepatitis c
Treatments sof/vel/vox, sof/vel
Phase phase 3
Sponsor Gilead Sciences
Start date November 2015
End date October 2016
Trial size 943 participants
Trial identifier NCT02607800, 2015-003460-36, GS-US-367-1172

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
SOF/VEL/VOX tablet for 8 weeks
sof/vel/vox GS-7977/GS-5816/GS-9857
SOF/VEL/VOX tablet administered orally once daily
(Active Comparator)
SOF/VEL tablet for 12 weeks
sof/vel GS-7977/GS-5816
SOF/VEL tablet administered orally once daily

Primary Outcomes

Measure
Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)
time frame: Posttreatment Week 12
Proportion of Participants Who Permanently Discontinue Study Drug Due to an Adverse Event
time frame: Up to 12 weeks

Secondary Outcomes

Measure
Proportion of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)
time frame: Posttreatment Weeks 4 and 24
Proportion of Participants With HCV RNA < LLOQ On Treatment
time frame: Up to 12 weeks
Change From Baseline in HCV RNA
time frame: Up to 12 weeks
Proportion of Participants With Virologic Failure
time frame: Up to Posttreatment Week 24

Eligibility Criteria

Male or female participants at least 18 years old.

Key Inclusion Criteria: - Willing and able to provide written informed consent - HCV RNA ≥ 10^4 IU/mL at screening - Chronic HCV infection (≥ 6 months) - HCV treatment naive or treatment experienced with an interferon (IFN)-based regimen - Use of protocol specified methods of contraception Key Exclusion Criteria: - Current or prior history of clinically significant illness that may interfere with participation in the study - Screening ECG with clinically significant abnormalities - Laboratory parameters outside the acceptable range at screening - Pregnant or nursing female - Chronic liver disease not caused by HCV - Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Gilead Sciences.