Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection

PHASE2CompletedINTERVENTIONAL
Enrollment

379

Participants

Timeline

Start Date

April 30, 2013

Primary Completion Date

May 31, 2014

Study Completion Date

August 31, 2014

Conditions
Hepatitis C
Interventions
DRUG

SOF

400 mg tablet administered orally once daily

DRUG

VEL

Tablet administered orally once daily

DRUG

RBV

200 mg 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 (51)

10021

Weill Cornell Medical College-New York Presbyterian Hospital, New York

11041

North Shore/Long Island Jewish PRIME, Lake Success

15213

UPMC Center For Liver Diseases, Pittsburgh

15240

VA Pittsburgh Healthcare System, Pittsburgh

19104

University of Pennsylvania Health System, Philadelphia

21202

Mercy Medical Ctr, Baltimore

21287

Johns Hopkins University, Baltimore

22031

Metropolitan Research, Fairfax

22042

INOVA Institute of Research & Education, Falls Church

23502

Digestive and Liver Disease Specialists, Ltd., Norfolk

23602

The Liver Institute of Virginia, Newport News

27103

Digestive Health Specialists, PA, Winston-Salem

27710

Duke University Medical Center, Durham

28303

Cumberland Research Associates, LLC, Fayetteville

28801

Asheville Gastroenterology Associates, P.A., Asheville

30060

Gastrointestinal Specialists of Georgia, PC, Marietta

30344

Center For Hepatitis C/Atlanta Medical Center, Atlanta

32216

Borland-Groover Clinic, Jacksonville

32610

University of Florida Center for Clinical Trials Research, Gainesville

32803

Orlando Immunology Center, Orlando

33136

University of Miami, Miami

33414

South Florida Center of Gastroenterology, P.A, Wellington

33606

Tampa General Hospital, Tampa

37211

Nashville Gastrointestinal Specialists Inc., Nashville

38138

Gastro One, Germantown

46202

Indiana University School of Medicine, Indianapolis

46237

Indianapolis Gastroenterology & Hepatology, Inc.- ARC, Indianapolis

48202

Henry Ford Health System, Detroit

60611

Northwestern University, Chicago

75203

Methodist Transplant Physicians, Dallas

76012

Texas Clinical Research Institute, LLC, Arlington

78215

Alamo Medical Research, LTD d/b/a American Research Corporation, San Antonio

80220

University of Colorado, Denver

87505

Southwest C.A.R.E. Center, Santa Fe

90027

Los Angeles Medical Center, Los Angeles

90036

Ruane Peter J MD Incorporated, Los Angeles

90048

Cedars Sinai Medical Center, Los Angeles

90057

National Research Institute, Los Angeles

90822

VA Long Beach Healthcare System, Long Beach

91105

Huntington Medical Research Institutes Liver Center, Pasadena

92037

UCSD, La Jolla

92093

University of California San Diego Medical Center, La Jolla

92120

Kaiser Permanente Medical Grp, San Diego

92123

Medical Associates Research Group, Inc., San Diego

94080

Kaiser Permante, San Francisco

98101

Virginia Mason Medical Center, Seattle

02114

Massachusetts General Hospital, Boston

02215

Beth Israel Deaconess Medical Center, Boston

08844

ID Care, Hillsborough

02905

University Gastroenterology, Providence

00909

Fundacion de Investigacion de Diego, Santurce

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT01858766 - Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection | Biotech Hunter | Biotech Hunter