Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Adults With Chronic Genotype 2 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:September 2014
End Date:September 2015

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

A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 12 Weeks in Subjects With Chronic Genotype 2 HCV Infection

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
of treatment with sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) for 12 weeks
compared to treatment with sofosbuvir (SOF) plus ribavirin (RBV) for 12 weeks in participants
with chronic genotype 2 hepatitis C virus (HCV) infection.


Inclusion Criteria:

- Willing and able to provide written informed consent

- HCV RNA ≥ 10^4 IU/mL

- HCV genotype 2

- Chronic HCV infection (≥ 6 months)

- Females of childbearing potential must have a negative serum pregnancy test

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

- Must be of generally good health, with the exception of chronic HCV infection, as
determined by the investigator.

Exclusion Criteria:

- Current or prior history of clinically-significant illness (other than HCV that may
interfere with treatment, assessment or compliance with the protocol;

- Screening electrocardiogram (ECG) with clinically significant abnormalities

- Laboratory results outside of acceptable ranges at Screening

- Pregnant or nursing female or male with pregnant female partner

- Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease,
alfa-1 antitrypsin deficiency, cholangitis)

- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
We found this trial at
51
sites
1026
mi
from 98109
Aurora, CO
Click here to add this to my saved trials
201 Dowman Dr
Atlanta, Georgia 30303
(404) 727-6123
Emory University Emory University, recognized internationally for its outstanding liberal artscolleges, graduate and professional schools,...
2178
mi
from 98109
Atlanta, GA
Click here to add this to my saved trials
1671
mi
from 98109
Arlington, TX
Click here to add this to my saved trials
2187
mi
from 98109
Asheville, NC
Click here to add this to my saved trials
2178
mi
from 98109
Atlanta, GA
Click here to add this to my saved trials
2328
mi
from 98109
Baltimore, MD
Click here to add this to my saved trials
2485
mi
from 98109
Boston, MA
Click here to add this to my saved trials
2543
mi
from 98109
Bradenton, FL
Click here to add this to my saved trials
2402
mi
from 98109
Bronx, NY
Click here to add this to my saved trials
1733
mi
from 98109
Chicago, IL
Click here to add this to my saved trials
1733
mi
from 98109
Chicago, IL
Click here to add this to my saved trials
1933
mi
from 98109
Detroit, MI
Click here to add this to my saved trials
2450
mi
from 98109
Gainesville, FL
Click here to add this to my saved trials
1877
mi
from 98109
Germantown, TN
Click here to add this to my saved trials
2412
mi
from 98109
Great Neck, NY
Click here to add this to my saved trials
1867
mi
from 98109
Indianapolis, IN
Click here to add this to my saved trials
2449
mi
from 98109
Jacksonville, FL
Click here to add this to my saved trials
979
mi
from 98109
Long Beach, CA
Click here to add this to my saved trials
962
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
962
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
962
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
962
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
962
mi
from 98109
Los Angeles, CA
Click here to add this to my saved trials
?
mi
from 98109
Lutherville, MD
Click here to add this to my saved trials
2164
mi
from 98109
Marietta, GA
Click here to add this to my saved trials
2730
mi
from 98109
Miami, FL
Click here to add this to my saved trials
1890
mi
from 98109
Monroe, LA
Click here to add this to my saved trials
1970
mi
from 98109
Nashville, TN
Click here to add this to my saved trials
2400
mi
from 98109
New York, NY
Click here to add this to my saved trials
2400
mi
from 98109
New York, NY
Click here to add this to my saved trials
2429
mi
from 98109
Norfolk, VA
Click here to add this to my saved trials
2544
mi
from 98109
Orlando, FL
Click here to add this to my saved trials
704
mi
from 98109
Palo Alto, CA
Click here to add this to my saved trials
956
mi
from 98109
Pasadena, CA
Click here to add this to my saved trials
2373
mi
from 98109
Philadelphia, PA
Click here to add this to my saved trials
2132
mi
from 98109
Pittsburgh, PA
Click here to add this to my saved trials
2132
mi
from 98109
Pittsburgh, PA
Click here to add this to my saved trials
2486
mi
from 98109
Providence, RI
Click here to add this to my saved trials
2348
mi
from 98109
Richmond, VA
Click here to add this to my saved trials
2348
mi
from 98109
Richmond, VA
Click here to add this to my saved trials
626
mi
from 98109
Sacramento, CA
Click here to add this to my saved trials
1720
mi
from 98109
Saint Louis, MO
Click here to add this to my saved trials
1790
mi
from 98109
San Antonio, TX
Click here to add this to my saved trials
1065
mi
from 98109
San Diego, CA
Click here to add this to my saved trials
1065
mi
from 98109
San Diego, CA
Click here to add this to my saved trials
1065
mi
from 98109
San Diego, CA
Click here to add this to my saved trials
681
mi
from 98109
San Francisco, CA
Click here to add this to my saved trials
681
mi
from 98109
San Francisco, CA
Click here to add this to my saved trials
3726
mi
from 98109
San Juan,
Click here to add this to my saved trials
1180
mi
from 98109
Santa Fe, NM
Click here to add this to my saved trials
2686
mi
from 98109
Wellington, FL
Click here to add this to my saved trials