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Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection

NCT02201940 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 741

Last updated 2018-11-15

Study results available
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Summary

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.

Conditions

  • Hepatitis C Virus Infection

Interventions

DRUG

SOF/VEL

400/100 mg FDC tablet administered orally once daily

DRUG

Placebo

Tablet administered orally once daily

Sponsors & Collaborators

Principal Investigators

  • John McNally, PhD · Gilead Sciences

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-06-30
Completion
2015-09-30

Countries

  • United States
  • Belgium
  • Canada
  • China
  • France
  • Germany
  • Italy
  • Puerto Rico
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
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 NCT02201940 on ClinicalTrials.gov