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

PHASE3CompletedINTERVENTIONAL
Enrollment

239

Participants

Timeline

Start Date

April 12, 2016

Primary Completion Date

February 14, 2017

Study Completion Date

May 11, 2017

Conditions
Hepatitis C Virus Infection
Interventions
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)

Trial Locations (37)

Unknown

Bunkyō City

Chiba

Chūō

Ehime

Fukuoka

Fukuyama

Gifu

Ibaraki

Ikeda

Iruma-gun

Izunokuni

Kagoshima

Kashihara

Kitakyushu

Kumamoto

Kyoto

Maebashi

Matsumoto

Morioka

Musashino

Nagasaki

Nagoya

Nishinomiya

Okayama

Osaka

Ōgaki

Ōmura

Saga

Sagamihara

Sapporo

Sendai

Suita

tabashi City

Takamatsu

Ube

Yamagata

Yufu

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT02738333 - Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection | Biotech Hunter | Biotech Hunter