Overview

This trial is active, not recruiting.

Condition hepatitis c
Treatments sof/vel/vox, placebo
Phase phase 3
Sponsor Gilead Sciences
Start date November 2015
End date October 2016
Trial size 416 participants
Trial identifier NCT02607735, 2015-003455-21, GS-US-367-1171

Summary

This study will evaluate the safety and efficacy of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic HCV infection who have previously received treatment with direct-acting antiviral therapy.

Subjects randomized to placebo may be eligible for deferred treatment with active SOF/VEL/VOX.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
SOF/VEL/VOX tablet for 12 weeks
sof/vel/vox GS-7977/GS-5816/GS-9857
SOF/VEL/VOX tablet administered orally once daily
(Experimental)
Placebo to match SOF/VEL/VOX tablet for 12 weeks
placebo
SOF/VEL/VOX placebo tablet administered orally once daily
(Experimental)
SOF/VEL/VOX tablet for 12 weeks for eligible participants initially randomized to receive placebo
sof/vel/vox GS-7977/GS-5816/GS-9857
SOF/VEL/VOX tablet administered orally once daily

Primary Outcomes

Measure
Proportion of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12) (Primary Study)
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) (Primary Study)
time frame: Posttreatment Weeks 4 and 24
Proportion of Participants With HCV RNA < LLOQ On Treatment (Primary Study)
time frame: Up to 12 weeks
Change From Baseline in HCV RNA (Primary Study)
time frame: Up to 12 weeks
Proportion of Participants With Virologic Failure (Primary Study)
time frame: Up to Posttreatment Week 24
Proportion of Participants With SVR at 4, 12, and 24 Weeks After Discontinuation of Therapy (Deferred Treatment Substudy)
time frame: Posttreatment Weeks 4, 12, and 24 on active treatment
Proportion of Participants With HCV RNA < LLOQ On Treatment (Deferred Treatment Substudy)
time frame: Up to 12 weeks on active treatment
Change From Baseline in HCV RNA (Deferred Treatment Substudy)
time frame: Up to 12 weeks on active treatment
Proportion of Participants With Virologic Failure (Deferred Treatment Substudy)
time frame: Up to Posttreatment Week 24 on active treatment

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) - Treatment experienced with a direct acting antiviral medication for HCV - 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 results outside of acceptable ranges 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, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced 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.