NCT02202980

Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection

A Phase 2, Multicenter, Open-Label Study to Assess the Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 273 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.

Conditions

• Chronic Hepatitis C

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 package insert weight-based dosing recommendations (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)
DRUG	SOF/VEL	400/100 mg FDC tablet administered orally once daily
DRUG	VOX	100 mg tablet administered orally once daily with food

Timeline

• Start date: 2014-08-04
• Primary completion: 2016-03-16
• Completion: 2016-05-09
• First posted: 2014-07-29
• Last updated: 2018-11-16
• Results posted: 2017-11-17

Locations

2 sites across 1 country: New Zealand

Regulatory

• FDA-regulated drug study