Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis

PHASE2CompletedINTERVENTIONAL
Enrollment

32

Participants

Timeline

Start Date

January 23, 2017

Primary Completion Date

September 25, 2018

Study Completion Date

December 12, 2018

Conditions
Hepatitis C Virus Infection
Interventions
DRUG

SOF/VEL

400/100 mg FDC tablet administered orally once daily

DRUG

RBV

Tablets administered orally at 600 mg, if well tolerated then up to a maximum total daily dose of 1000 to 1200 mg (based on weight) divided twice daily.

Trial Locations (12)

10029

Icahn School of Medicine at Mount Sinai, New York

19104

Hospital of the University of Pennsylvania, Philadelphia

21228

Digestive Disease Associates, PA, Catonsville

23226

Bon Secours St. Mary's Hospital of Richmond, Inc. d/b/a Bon Secours Liver Institute of Virginia, Richmond

33606

Tampa General Medical Group, Tampa

39216

Southern Therapy and Advanced Research LLC, Jackson

60611

Northwestern Memorial Hospital; Clinical Research Unit, Chicago

78215

American Research Corporation at Texas Liver Institute, San Antonio

84107

Intermountain Liver Disease and Transplant Center, Murray

94010

Hopital Henri Mondor, Créteil

94800

Hopital Paul Brousse, Villejuif

98105

University of Washington/ Harborview Medical Center, Seattle

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Gilead Sciences

INDUSTRY

NCT02994056 - Evaluate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Ribavirin for 12 Weeks in Participants With Chronic HCV Infection and Child-Pugh-Turcotte Class C Cirrhosis | Biotech Hunter | Biotech Hunter