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Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Participants With Chronic Genotype 1 HCV Infection

NCT02021656 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2020-03-05

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 ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in treatment-naive and treatment-experienced participants with chronic genotype 1 hepatitis C virus (HCV) infection.

Conditions

  • Chronic HCV Infection

Interventions

DRUG

LDV/SOF

90/400 mg FDC tablet administered orally once daily without regard to food

Sponsors & Collaborators

Principal Investigators

  • Gilead Study Director · Gilead Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-12-10
Primary Completion
2017-07-08
Completion
2017-09-29

Countries

  • China
  • South Korea
  • Taiwan

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 NCT02021656 on ClinicalTrials.gov