Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination (FDC) With and Without Ribavirin for the Treatment of HCV

PHASE3CompletedINTERVENTIONAL
Enrollment

870

Participants

Timeline

Start Date

September 30, 2012

Primary Completion Date

March 31, 2014

Study Completion Date

April 30, 2014

Conditions
Chronic Hepatitis C Virus
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 (\< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

Trial Locations (88)

Unknown

Birmingham

La Jolla

Long Beach

Los Angeles

Palo Alto

Sacramento

San Diego

Aurora

Englewood

Washington D.C.

Gainesville

Miami

Orlando

Tampa

Wellington

Atlanta

Decatur

Marietta

Chicago

Indianapolis

Baltimore

Lutherville

Boston

Detroit

Rochester

Saint Paul

Kansas City

St Louis

Hillsborough

Albuquerque

Santa Fe

Manhasset

New York

The Bronx

Asheville

Chapel Hill

Durham

Fayetteville

Statesville

Winston-Salem

Cincinnati

Philadelphia

Germantown

Nashville

Arlington

Dallas

Houston

San Antonio

Fairfax

Falls Church

Norfolk

Richmond

Seattle

CHRU Lille

Clichy

Créteil

La Tronche

Lyon

Marseille

Nice

Paris

Berlin

Cologne

Düsseldorf

Essen

Frankfurt

Freiburg im Breisgau

Hamburg

Hanover

Mainz

Bologna

Brescia

Milan

Padua

Palermo

Roma

San Giovanni Rotondo

Torino

San Juan

Barcelona

Madrid

Málaga

Santander

Seville

Birmingham

London

Manchester

Plymouth

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY