NCT02600351

Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Participants Who Have Failed Prior Treatment With Sofosbuvir-based Therapies

A Phase 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir, With or Without Ribavirin, in HCV Infected Subjects Who Have Failed Prior Treatment With Sofosbuvir-based Therapies

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) fixed dose combination (FDC) for 12 weeks with or without ribavirin (RBV) in participants without cirrhosis, and LDV/SOF FDC for 12 weeks with RBV or LDV/SOF FDC for 24 weeks without RBV in participants with cirrhosis.

Conditions

• Hepatitis C Virus Infection

Interventions

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

Timeline

• Start date: 2015-11-11
• Primary completion: 2017-03-21
• Completion: 2017-05-29
• First posted: 2015-11-09
• Last updated: 2018-11-16
• Results posted: 2018-04-11

Locations

42 sites across 3 countries: United States, Canada, Puerto Rico

Regulatory

• FDA-regulated drug study