Efficacy And Safety Of Sofosbuvir/Velpatasvir Fixed Dose Combination With Ribavirin in Chronic HCV Infected Adults Who Participated in a Prior Gilead Sponsored HCV Treatment Study



Status:Completed
Conditions:Infectious Disease, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/18/2018
Start Date:December 1, 2014
End Date:September 15, 2016

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

An Open Label Study to Evaluate The Efficacy And Safety Of Sofosbuvir/GS-5816 Fixed Dose Combination With Ribavirin For 24 Weeks In Chronic HCV Infected Subjects Who Participated In A Prior Gilead Sponsored HCV Treatment Study

The primary objective of this study is to evaluate the efficacy, safety and tolerability of
treatment with sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) with ribavirin (RBV) for 24 weeks
in adults with chronic hepatitis C virus (HCV) infection who participated in a prior Gilead
sponsored study and did not achieve sustained virologic response (SVR).


Key Inclusion Criteria:

- Willing and able to provide written informed consent

- HCV genotype determined by the Central Laboratory

- HCV RNA > LLOQ at screening

- Participated and completed a Gilead sponsored HCV treatment study of direct acting
antiviral (DAA) containing regimens.

- Male and female of childbearing potential must agree to use protocol specified
method(s) of contraception

Key Exclusion Criteria:

- Current or prior history: Clinically-significant illness (other than HCV) or any other
major medical disorder that may interfere with treatment, assessment or compliance
with the protocol; individuals currently under evaluation for a potentially
clinically-significant illness (other than HCV) are also excluded.

- Screening ECG with clinically significant abnormalities

- Laboratory results outside of acceptable ranges at screening

- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
We found this trial at
24
sites
1051
mi
from
Durham, NC
Click here to add this to my saved trials
402
mi
from
Aurora, CO
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
349
mi
from
Dallas, TX
Click here to add this to my saved trials
8648
mi
from
Darlinghurst,
Click here to add this to my saved trials
1118
mi
from
Falls Church, 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
1252
mi
from
Hillsborough, NJ
Click here to add this to my saved trials
1053
mi
from
Jacksonville, FL
Click here to add this to my saved trials
1303
mi
from
Manhasset, NY
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
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
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
1111
mi
from
Richmond, VA
Click here to add this to my saved trials
583
mi
from
San Antonio, TX
Click here to add this to my saved trials
1143
mi
from
San Diego, CA
Click here to add this to my saved trials
1131
mi
from
San Marcos, CA
Click here to add this to my saved trials
1277
mi
from
Wellington, FL
Click here to add this to my saved trials