NCT02081079

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection

A Phase 2, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naive and Treatment-Experienced Subjects With Chronic Genotype 4 or 5 HCV Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) in participants with chronic genotype 4 or 5 hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained virologic response (SVR12), defined as HCV RNA \< lower limit of quantification (LLOQ) 12 weeks after discontinuation of therapy.

Conditions

• Chronic Genotype 4 HCV
• Chronic Genotype 5 HCV

Interventions

Type	Name	Description
DRUG	LDV/SOF	LDV/SOF (90/400 mg) FDC tablet administered orally once daily

Timeline

• Start date: 2014-03-01
• Primary completion: 2014-11-01
• Completion: 2015-02-01
• First posted: 2014-03-07
• Last updated: 2018-11-19
• Results posted: 2016-01-14

Locations

5 sites across 1 country: France