NCT01975675

Efficacy and Safety of Sofosbuvir/Ledipasvir ± Ribavirin in Japanese Participants With Chronic Genotype 1 HCV Infection

A Phase 3b, Randomized, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination ± Ribavirin in Treatment-Naïve and Treatment-Experienced Japanese Subjects With Chronic Genotype 1 HCV Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 341 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the antiviral efficacy of sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) tablet with or without ribavirin (RBV) in treatment-naive or treatment-experienced Japanese participants with chronic genotype 1 HCV infection. Participants receive 12 weeks of treatment and continue assessments during a 24-week posttreatment follow-up period.

Conditions

• Chronic HCV Infection

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 (≤ 60 kg = 600 mg, \> 60 kg to ≤ 80 kg = 800 mg, and ≥ 80 kg = 1000 mg)

Timeline

• Start date: 2013-10-01
• Primary completion: 2014-06-01
• Completion: 2014-08-01
• First posted: 2013-11-05
• Last updated: 2018-11-16
• Results posted: 2015-06-26

Locations

19 sites across 1 country: Japan