Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir in Adults With Chronic HCV Infection Who Have Previously Received Treatment With Direct-Acting Antiviral Therapy



Status:Completed
Conditions:Infectious Disease, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:3/7/2019
Start Date:November 11, 2015
End Date:June 21, 2017

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

A Phase 3, Global, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir/GS-9857 Fixed-Dose Combination for 12 Weeks in Direct-Acting Antiviral-Experienced Subjects With Chronic HCV Infection

The primary objectives of this study are to evaluate the safety and efficacy of treatment
with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) in adults with chronic hepatitis C
virus (HCV) infection who have previously received treatment with direct-acting antiviral
therapy.

Participants randomized to placebo may be eligible for deferred treatment with active
SOF/VEL/VOX.


Key Inclusion Criteria:

- Willing and able to provide written informed consent

- HCV RNA ≥ 10^4 IU/mL at screening

- Chronic HCV infection (≥ 6 months)

- Treatment experienced with a direct acting antiviral medication for HCV

- Use of protocol specified methods of contraception

Key Exclusion Criteria:

- Current or prior history of clinically significant illness that may interfere with
participation in the study

- Screening ECG with clinically significant abnormalities

- Laboratory results outside of acceptable ranges at screening

- Pregnant or nursing female

- Chronic liver disease not caused by HCV

- 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
44
sites
337
mi
from 43215
Catonsville, MD
Click here to add this to my saved trials
164
mi
from 43215
Ann Arbor, MI
Click here to add this to my saved trials
302
mi
from 43215
Asheville, NC
Click here to add this to my saved trials
436
mi
from 43215
Atlanta, GA
Click here to add this to my saved trials
1154
mi
from 43215
Aurora, CO
Click here to add this to my saved trials
344
mi
from 43215
Baltimore, MD
Click here to add this to my saved trials
643
mi
from 43215
Boston, MA
Click here to add this to my saved trials
482
mi
from 43215
Bronx, NY
Click here to add this to my saved trials
9459
mi
from 43215
Camperdown,
Click here to add this to my saved trials
274
mi
from 43215
Chicago, IL
Click here to add this to my saved trials
163
mi
from 43215
Detroit, MI
Click here to add this to my saved trials
1163
mi
from 43215
Englewood, CO
Click here to add this to my saved trials
320
mi
from 43215
Falls Church, VA
Click here to add this to my saved trials
711
mi
from 43215
Gainesville, FL
Click here to add this to my saved trials
501
mi
from 43215
Germantown, TN
Click here to add this to my saved trials
442
mi
from 43215
Hillsborough, NJ
Click here to add this to my saved trials
991
mi
from 43215
Houston, TX
Click here to add this to my saved trials
166
mi
from 43215
Indianapolis, IN
Click here to add this to my saved trials
618
mi
from 43215
Kansas City, MO
Click here to add this to my saved trials
283
mi
from 43215
Knoxville, TN
Click here to add this to my saved trials
1975
mi
from 43215
Long Beach, CA
Click here to add this to my saved trials
1972
mi
from 43215
Los Angeles, CA
Click here to add this to my saved trials
394
mi
from 43215
Madison, WI
Click here to add this to my saved trials
425
mi
from 43215
Marietta, GA
Click here to add this to my saved trials
993
mi
from 43215
Miami, FL
Click here to add this to my saved trials
1514
mi
from 43215
Murray, UT
Click here to add this to my saved trials
331
mi
from 43215
Nashville, TN
Click here to add this to my saved trials
481
mi
from 43215
New York, NY
Click here to add this to my saved trials
422
mi
from 43215
Norfolk, VA
Click here to add this to my saved trials
792
mi
from 43215
Orlando, FL
Click here to add this to my saved trials
2100
mi
from 43215
Palo Alto, CA
Click here to add this to my saved trials
1964
mi
from 43215
Pasadena, CA
Click here to add this to my saved trials
416
mi
from 43215
Philadelphia, PA
Click here to add this to my saved trials
162
mi
from 43215
Pittsburgh, PA
Click here to add this to my saved trials
619
mi
from 43215
Providence, RI
Click here to add this to my saved trials
1924
mi
from 43215
Rialto, CA
Click here to add this to my saved trials
341
mi
from 43215
Richmond, VA
Click here to add this to my saved trials
394
mi
from 43215
Saint Louis, MO
Click here to add this to my saved trials
1144
mi
from 43215
San Antonio, TX
Click here to add this to my saved trials
1951
mi
from 43215
San Diego, CA
Click here to add this to my saved trials
2107
mi
from 43215
San Francisco, CA
Click here to add this to my saved trials
2005
mi
from 43215
Seattle, WA
Click here to add this to my saved trials
328
mi
from 43215
Washington,
Click here to add this to my saved trials
933
mi
from 43215
Wellington, FL
Click here to add this to my saved trials