Efficacy and Safety of Sofosbuvir/Ledipasvir ± Ribavirin in Japanese Participants With Chronic Genotype 1 HCV Infection

PHASE3CompletedINTERVENTIONAL
Enrollment

341

Participants

Timeline

Start Date

October 31, 2013

Primary Completion Date

June 30, 2014

Study Completion Date

August 31, 2014

Conditions
Chronic HCV Infection
Interventions
DRUG

LDV/SOF

LDV/SOF 90/400 mg FDC tablet administered orally once daily

DRUG

RBV

RBV tablets 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 (19)

272-8516

Ichikawa

830-0011

Kurume

503-0864

Ōgaki

060-8648

Sapporo

663-8501

Nishinomiya

390-8621

Matsumoto

856-8562

Ōmura

565-0871

Suita

410-2295

Izunokuni

101-8643

Chiyoda-ku

173-8610

Itabashi-ku

180-8610

Musashino

162-8566

Shinjuku

400-0027

Kofu

010-0933

Akita

260-0856

Chiba

500-8513

Gifu

700-8558

Okayama

990-9585

Yamagata

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT01975675 - Efficacy and Safety of Sofosbuvir/Ledipasvir ± Ribavirin in Japanese Participants With Chronic Genotype 1 HCV Infection | Biotech Hunter | Biotech Hunter