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
2336
mi
from 91732
Norfolk, VA
Click here to add this to my saved trials
5586
mi
from 91732
Antwerp,
Click here to add this to my saved trials
1919
mi
from 91732
Atlanta, GA
Click here to add this to my saved trials
825
mi
from 91732
Aurora, CO
Click here to add this to my saved trials
825
mi
from 91732
Aurora, CO
Click here to add this to my saved trials
2301
mi
from 91732
Baltimore, MD
Click here to add this to my saved trials
2578
mi
from 91732
Boston, MA
Click here to add this to my saved trials
2436
mi
from 91732
Bronx, NY
Click here to add this to my saved trials
2436
mi
from 91732
Bronx, NY
Click here to add this to my saved trials
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
1729
mi
from 91732
Chicago, IL
Click here to add this to my saved trials
1966
mi
from 91732
Detroit, MI
Click here to add this to my saved trials
1966
mi
from 91732
Detroit, MI
Click here to add this to my saved trials
2103
mi
from 91732
Gainesville, FL
Click here to add this to my saved trials
2103
mi
from 91732
Gainesville, FL
Click here to add this to my saved trials
1600
mi
from 91732
Germantown, TN
Click here to add this to my saved trials
1793
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
1793
mi
from 91732
Indianapolis, IN
Click here to add this to my saved trials
2127
mi
from 91732
Jacksonville, FL
Click here to add this to my saved trials
1463
mi
from 91732
Little Rock, AR
Click here to add this to my saved trials
21
mi
from 91732
Long Beach, CA
Click here to add this to my saved trials
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
13
mi
from 91732
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from 91732
Lutherville, MD
Click here to add this to my saved trials
?
mi
from 91732
Lutherville, MD
Click here to add this to my saved trials
1908
mi
from 91732
Marietta, GA
Click here to add this to my saved trials
2321
mi
from 91732
Miami, FL
Click here to add this to my saved trials
1763
mi
from 91732
Nashville, TN
Click here to add this to my saved trials
2435
mi
from 91732
New York, NY
Click here to add this to my saved trials
2435
mi
from 91732
New York, NY
Click here to add this to my saved trials
2182
mi
from 91732
Orlando, FL
Click here to add this to my saved trials
329
mi
from 91732
Palo Alto, CA
Click here to add this to my saved trials
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
2375
mi
from 91732
Philadelphia, PA
Click here to add this to my saved trials
2119
mi
from 91732
Pittsburgh, PA
Click here to add this to my saved trials
2119
mi
from 91732
Pittsburgh, PA
Click here to add this to my saved trials
2562
mi
from 91732
Providence, RI
Click here to add this to my saved trials
2562
mi
from 91732
Providence, RI
Click here to add this to my saved trials
2267
mi
from 91732
Richmond, VA
Click here to add this to my saved trials
364
mi
from 91732
Sacramento, CA
Click here to add this to my saved trials
1188
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
1188
mi
from 91732
San Antonio, TX
Click here to add this to my saved trials
105
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
105
mi
from 91732
San Diego, CA
Click here to add this to my saved trials
2294
mi
from 91732
Wellington, FL
Click here to add this to my saved trials