Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection

PHASE3CompletedINTERVENTIONAL
Enrollment

441

Participants

Timeline

Start Date

January 31, 2013

Primary Completion Date

November 30, 2013

Study Completion Date

February 28, 2014

Conditions
Chronic Hepatitis C Virus
Interventions
DRUG

LDV/SOF

Ledipasvir (LDV) 90 mg/sofosbuvir (SOF) 400 mg fixed-dose combination (FDC) tablet administered orally once daily

DRUG

RBV

Ribavirin (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)

Trial Locations (53)

Unknown

Phoenix

Tucson

La Jolla

Los Angeles

Palo Alto

San Diego

San Francisco

Aurora

Englewood

Washington D.C.

Gainesville

Jacksonville

Miami

Orlando

Atlanta

Marietta

Chicago

Indianapolis

Bowling Green

Baton Rouge

Baltimore

Lutherville

Boston

Springfield

Detroit

Rochester

Saint Louis

Saint Paul

Kansas City

Berlin

Hillsborough

Albuquerque

Santa Fe

Binghamton

Manhasset

New York

Asheville

Charlotte

Durham

Fayetteville

Statesville

Winston-Salem

Philadelphia

Providence

Germantown

Nashville

Arlington

Dallas

Houston

San Antonio

Fairfax

Newport News

Norfolk

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT01768286 - Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin in Treatment-Experienced Subjects With Genotype 1 HCV Infection | Biotech Hunter | Biotech Hunter