NCT02738333

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

A Phase 3b, Multicenter, Randomized, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 239 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hepatitis C Virus Infection

Interventions

Type	Name	Description
DRUG	LDV/SOF	90/400 mg FDC tablet administered orally once daily
DRUG	SOF	400 mg tablet administered orally once daily
DRUG	RBV	Capsules 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: 2016-04-12
• Primary completion: 2017-02-14
• Completion: 2017-05-11
• First posted: 2016-04-14
• Last updated: 2018-11-16
• Results posted: 2018-03-14

Locations

37 sites across 1 country: Japan

Regulatory

• FDA-regulated drug study