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Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Participants With Chronic HCV

NCT02671500 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2019-01-08

Study results available
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Summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed-dose combination (FDC) for 12 weeks in participants with chronic hepatitis C virus (HCV) infection.

Conditions

  • Hepatitis C Virus Infection

Interventions

DRUG

SOF/VEL

SOF/VEL (400/100 mg) FDC tablet administered orally once daily

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-19
Primary Completion
2018-01-05
Completion
2018-03-27
FDA Drug
Yes

Countries

  • China
  • Malaysia
  • Singapore
  • Thailand
  • Vietnam

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02671500 on ClinicalTrials.gov