Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection



Status:Completed
Conditions:Infectious Disease, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/17/2018
Start Date:July 2014
End Date:September 2015

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

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with
chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.


Inclusion Criteria:

- Willing and able to provide written informed consent

- HCV RNA ≥ 10^4 IU/mL at screening

- HCV genotype 1, 2, 4, 5, 6, or indeterminate assessed at screening by the central
laboratory

- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

- Classification as treatment naive or treatment experienced

- Males and females of childbearing potential who engage in heterosexual intercourse
must agree to use protocol specified method(s) of contraception

Exclusion Criteria:

- Current or prior history of 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

- Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A
inhibitor

- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
We found this trial at
46
sites
1277
mi
from
Wellington, FL
Click here to add this to my saved trials
4706
mi
from
Antwerp,
Click here to add this to my saved trials
801
mi
from
Atlanta, GA
Click here to add this to my saved trials
402
mi
from
Aurora, CO
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
1291
mi
from
Bronx, NY
Click here to add this to my saved trials
1291
mi
from
Bronx, NY
Click here to add this to my saved trials
610
mi
from
Chicago, IL
Click here to add this to my saved trials
610
mi
from
Chicago, IL
Click here to add this to my saved trials
841
mi
from
Detroit, MI
Click here to add this to my saved trials
841
mi
from
Detroit, MI
Click here to add this to my saved trials
1047
mi
from
Gainesville, FL
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
643
mi
from
Indianapolis, IN
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
372
mi
from
Little Rock, AR
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
1168
mi
from
Los Angeles, 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
?
mi
from
Lutherville, MD
Click here to add this to my saved trials
?
mi
from
Lutherville, MD
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
1290
mi
from
New York, NY
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
1328
mi
from
Palo Alto, CA
Click here to add this to my saved trials
1225
mi
from
Philadelphia, PA
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
971
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
1424
mi
from
Providence, RI
Click here to add this to my saved trials
1424
mi
from
Providence, RI
Click here to add this to my saved trials
1111
mi
from
Richmond, VA
Click here to add this to my saved trials
1278
mi
from
Sacramento, CA
Click here to add this to my saved trials
583
mi
from
San Antonio, TX
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
1143
mi
from
San Diego, CA
Click here to add this to my saved trials