Safety and Efficacy of Sofosbuvir Plus Velpatasvir With or Without Ribavirin in Treatment-experienced Subjects With Chronic HCV Infection



Status:Completed
Conditions:Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/17/2018
Start Date:June 2013
End Date:August 2014

Use our guide to learn which trials are right for you!

A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Experienced Subjects With Chronic HCV Infection

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and
tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV)
in treatment-naive adults with chronic genotype (GT) 1 or 3 hepatitis C virus (HCV)
infection.


Inclusion Criteria:

- Body mass index (BMI) ≥ 18 kg/m^2

- HCV RNA ≥ 10000 IU/mL at screening

- Prior treatment failure to a regimen including interferon with or without RBV

- HCV genotype 1 or 3

- Chronic HCV infection

- Cirrhosis determination

- Use of highly effective contraception methods if female of childbearing potential or
sexually active male

Exclusion Criteria:

- Current or prior history of clinically significant illness other than HCV

- Screening ECG with clinically significant abnormalities

- Prior exposure to HCV specific direct acting antiviral agent

- Pregnant or nursing female or male with pregnant female partner

- Chronic liver disease of non-HCV etiology

- Hepatitis B

- Active drug abuse

- Use of any prohibited concomitant medications
We found this trial at
41
sites
1143
mi
from
San Diego, CA
Click here to add this to my saved trials
1118
mi
from
Annandale, VA
Click here to add this to my saved trials
353
mi
from
Arlington, TX
Click here to add this to my saved trials
858
mi
from
Asheville, NC
Click here to add this to my saved trials
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
1148
mi
from
Baltimore, MD
Click here to add this to my saved trials
1444
mi
from
Boston, MA
Click here to add this to my saved trials
8650
mi
from
Camperdown,
Click here to add this to my saved trials
610
mi
from
Chicago, IL
Click here to add this to my saved trials
349
mi
from
Dallas, TX
Click here to add this to my saved trials
409
mi
from
Denver, CO
Click here to add this to my saved trials
841
mi
from
Detroit, MI
Click here to add this to my saved trials
1051
mi
from
Durham, NC
Click here to add this to my saved trials
1114
mi
from
Fairfax, VA
Click here to add this to my saved trials
Fayetteville, North Carolina 28304
1067
mi
from
Fayetteville, NC
Click here to add this to my saved trials
1047
mi
from
Gainesville, FL
Click here to add this to my saved trials
481
mi
from
Germantown, TN
Click here to add this to my saved trials
1301
mi
from
Great Neck, NY
Click here to add this to my saved trials
1252
mi
from
Hillsborough, NJ
Click here to add this to my saved trials
643
mi
from
Indianapolis, IN
Click here to add this to my saved trials
1053
mi
from
Jacksonville, FL
Click here to add this to my saved trials
1171
mi
from
Long Beach, CA
Click here to add this to my saved trials
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
788
mi
from
Marietta, GA
Click here to add this to my saved trials
1320
mi
from
Miami, FL
Click here to add this to my saved trials
618
mi
from
Nashville, TN
Click here to add this to my saved trials
1290
mi
from
New York, NY
Click here to add this to my saved trials
1170
mi
from
Newport News, VA
Click here to add this to my saved trials
1181
mi
from
Norfolk, VA
Click here to add this to my saved trials
1139
mi
from
Orlando, FL
Click here to add this to my saved trials
1161
mi
from
Pasadena, CA
Click here to add this to my saved trials
1225
mi
from
Philadelphia, PA
Click here to add this to my saved trials
971
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
1383
mi
from
Portland, OR
Click here to add this to my saved trials
1424
mi
from
Providence, RI
Click here to add this to my saved trials
583
mi
from
San Antonio, TX
Click here to add this to my saved trials
475
mi
from
Santa Fe, NM
Click here to add this to my saved trials
1410
mi
from
Seattle, WA
Click here to add this to my saved trials
1117
mi
from
Tampa, FL
Click here to add this to my saved trials
1277
mi
from
Wellington, FL
Click here to add this to my saved trials
976
mi
from
Winston-Salem, NC
Click here to add this to my saved trials