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Clinical Trials/NCT03118843
NCT03118843CompletedPhase 3

An Open-Label Study to Evaluate the Safety And Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects Who Participated in a Prior Gilead-Sponsored HCV Treatment Study

Gilead Sciences27 sites in 7 countries31 target enrollmentStarted: April 25, 2017Last updated:
Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
31
Locations
27
Primary Endpoint
Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

Study Overview

Brief Summary

The primary objectives of this study are to determine the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection with or without cirrhosis, who did not achieve sustained viral response (SVR) after receiving prior treatment in a Gilead-sponsored HCV treatment study of direct-acting antiviral (DAA)-containing regimens.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Chronically HCV-infected males and non-pregnant/non-lactating females aged 18 years or older who did not achieve sustained virologic response (SVR) in a prior Gilead-sponsored HCV treatment study
  • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Exclusion Criteria

  • Not provided

Arms & Interventions

SOF/VEL/VOX

Experimental

SOF/VEL/VOX for 12 weeks

Intervention: SOF/VEL/VOX (Drug)

Outcomes

Primary Outcomes

Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

Time Frame: Posttreatment Week 12

SVR12 was defined as HCV RNA \< the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

Time Frame: Up to Week 12

Secondary Outcomes

  • Percentage of Participants With HCV RNA < LLOQ On Treatment(Weeks 2, 4, 8, and 12)
  • Percentage of Participants With Virologic Failure(Up to Posttreatment Week 12)
  • Percentage of Participants With SVR at 4 Weeks After Discontinuation of Therapy (SVR4)(Posttreatment Week 4)
  • Change From Baseline in HCV RNA(Baseline; Weeks 2, 4, 8, and 12)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (27)

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