Safety and Efficacy of Ledipasvir/Sofosbuvir Fixed-Dose Combination ± Ribavirin for the Treatment of HCV (ION-3)

PHASE3CompletedINTERVENTIONAL
Enrollment

647

Participants

Timeline

Start Date

May 31, 2013

Primary Completion Date

December 31, 2013

Study Completion Date

March 31, 2014

Conditions
Chronic Hepatitis C Virus
Interventions
DRUG

LDV/SOF

LDV 90 mg/SOF 400 mg 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 (52)

Unknown

Birmingham

La Jolla

Los Angeles

Palo Alto

Sacramento

San Diego

San Francisco

Aurora

Englewood

Washington D.C.

Gainesville

Jacksonville

Miami

Orlando

Wellington

Atlanta

Decatur

Marietta

Chicago

Indianapolis

Bowling Green

Baton Rouge

Baltimore

Lutherville

Boston

Novi

Kansas City

St Louis

Albuquerque

Berlin

Hillsborough

Santa Fe

Binghamton

Manhasset

New York

Chapel Hill

Fayetteville

Statesville

Winston-Salem

Philadelphia

Providence

Germantown

Nashville

Arlington

Houston

San Antonio

Fairfax

Falls Church

Newport News

Norfolk

Richmond

Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY