Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection

PHASE2CompletedINTERVENTIONAL
Enrollment

205

Participants

Timeline

Start Date

February 17, 2015

Primary Completion Date

February 1, 2016

Study Completion Date

April 12, 2016

Conditions
Hepatitis C Virus Infection
Interventions
DRUG

VOX

100 mg tablet(s) administered orally once daily with food

DRUG

SOF/VEL

400/100 mg FDC tablet administered orally once daily with food

DRUG

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 (34)

Unknown

Cedars Sinai Medical Center, Los Angeles

Stanford University, Palo Alto

Huntington Memorial Hospital Liver Center, Pasadena

Medical Associates Research Group, Inc., San Diego

University of Colorado, Denver

Borland-Groover Clinic, Jacksonville

University of Miami, Miami

Orlando Immunology center, Orlando

South Florida Center of Gastroenterology, P.A., Wellington

Center for Hep C/Atlanta Medical Center, Atlanta

Gastrointestinal Specialists of Georgia, PC, Marietta

University of Chicago, Chicago

Indiana University, Indianapolis

Indianapolis Gastroenterology & Hepatology, Inc., Indianapolis

Beth Isreal Deconess Medical Center, Boston

Massachusetts General Hospital, Boston

Henry Ford Hospital and Health System, Detroit

ID Care, Hillsborough

Southwest Care Center, Santa Fe

North Shore/Long Island Jewish PRIME, Manhasset

Mount Sinai Beth Israel, New York

Cumberland Research Associates, LLC, Fayetteville

Digestive Health Specialists, PA, Winston-Salem

University of Pennsylvania Health Systems, Philadelphia

UPMC Center for Liver Diseases, Pittsburgh

Medical University of South Carolina, Charleston

Gastro One, Germantown

Nashville Gastrointestinal Specialists, Inc., Nashville

Texas Liver Institute, San Antonio

Liver Institute of Virginia, Richmond

Swedish Medical Center, Seattle

Auckland Clinical Studies, Auckland

Christchurch Clinical Studies Trust, Christchurch

Fundacion de Investigacion de Diego, San Juan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT02378935 - Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Genotype 1 HCV Infection | Biotech Hunter | Biotech Hunter