NCT01701401

Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV

A Phase 3, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5885 Fixed-Dose Combination (FDC) +/- Ribavirin for 12 and 24 Weeks in Treatment-Naive Subjects With Chronic Genotype 1 HCV Infection.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 870 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the safety, tolerability, and antiviral efficacy of ledipasvir (LDV)/sofosbuvir (SOF) fixed-dose combination (FDC) tablets with or without ribavirin (RBV) administered for 12 and 24 weeks in treatment-naive subjects with chronic genotype 1 HCV infection.

Conditions

• Chronic Hepatitis C Virus

Interventions

Type	Name	Description
DRUG	LDV/SOF	LDV/SOF 90/400 mg FDC tablet administered orally once daily
DRUG	RBV	RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Timeline

• Start date: 2012-09-01
• Primary completion: 2014-03-01
• Completion: 2014-04-01
• First posted: 2012-10-05
• Last updated: 2018-11-16
• Results posted: 2015-03-27

Locations

88 sites across 7 countries: United States, France, Germany, Italy, Puerto Rico, Spain, United Kingdom