drugset / Trial / NCT02738333

Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection

NCT02738333

Phase 3 Completed 239 enrolled Gilead Sciences
RandomizedParallel-groupOpen-labelTreatment

Summary

The primary objectives of this study are to evaluate the antiviral efficacy of therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) and to evaluate the safety and tolerability of LDV/SOF FDC and sofosbuvir (SOF) + ribavirin (RBV) in participants with chronic genotype 2 hepatitis C virus (HCV) infection.

Timeline

Start
2016-04-12
Primary completion
2017-02-14
Completion
2017-05-11

Drugs

EvaluationDrugModalityDoseRoute
Subject LDV/SOF Unknown 90 mg Oral
Subject LDV/SOF Unknown 400 mg Oral
Subject Ribavirin Small molecule 600 mg Oral
Subject Ribavirin Small molecule 800 mg Oral
Subject Ribavirin Small molecule 1000 mg Oral
Subject Sofosbuvir Small molecule 400 mg Oral