Safety and Efficacy of Sofosbuvir + Velpatasvir With or Without Ribavirin in Treatment-Naive Adults With Chronic HCV Infection



Status:Completed
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/16/2018
Start Date:April 2013
End Date:August 2014

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

A Phase 2, Multicenter, Randomized, Open-Label Study to Investigate the Safety and Efficacy of Sofosbuvir + GS-5816 for 12 Weeks in Treatment-Naive Subjects With Chronic HCV Infection

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and
tolerability of sofosbuvir (SOF) + velpatasvir (VEL; GS-5816) with or without ribavirin (RBV)
in treatment-naive adults with chronic genotype (GT) 1, 2, 3, 4, 5, or 6 hepatitis C virus
(HCV) infection.


Inclusion Criteria:

- Chronic HCV infection

- Body mass index (BMI) ≥ 18 kg/m^2

- HCV RNA ≥ 10000 IU/mL at screening

- Use of highly effective contraception methods if female of childbearing potential or
sexually active male

- Must not have cirrhosis

Exclusion Criteria:

- Current or prior history of clinically significant illness other than HCV

- Screening ECG with clinically significant abnormalities

- Prior exposure to HCV specific direct acting antiviral agent

- Prior treatment of HCV with interferon or ribavirin

- Pregnant or nursing female or male with pregnant female partner

- Chronic liver disease of non-HCV etiology

- Hepatitis B

- Active drug abuse

- Use of any prohibited concomitant medications
We found this trial at
51
sites
Pittsburgh, Pennsylvania 15213
973
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
3400 N Charles St
Baltimore, Maryland 21205
410-516-8000
Johns Hopkins University The Johns Hopkins University opened in 1876, with the inauguration of its...
1148
mi
from
Baltimore, MD
Click here to add this to my saved trials
185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
1443
mi
from
Boston, MA
Click here to add this to my saved trials
330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
1444
mi
from
Boston, MA
Click here to add this to my saved trials
4800 Belfort Rd # 2
Jacksonville, Florida 32256
1062
mi
from
Jacksonville, FL
Click here to add this to my saved trials
2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
1170
mi
from
Los Angeles, CA
Click here to add this to my saved trials
8700 Beverly Blvd # 8211
Los Angeles, California 90048
(1-800-233-2771)
Cedars Sinai Med Ctr Cedars-Sinai is known for providing the highest quality patient care. Our...
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
1319
mi
from
Miami, FL
Click here to add this to my saved trials
1 Tampa General Cir
Tampa, Florida 33606
(813) 844-7000
Tampa General Hospital In a diverse city known for its rich culture and beautiful beaches,...
1117
mi
from
Tampa, FL
Click here to add this to my saved trials
Arlington, Texas 76012
348
mi
from
Arlington, TX
Click here to add this to my saved trials
Asheville, North Carolina 28801
857
mi
from
Asheville, NC
Click here to add this to my saved trials
800
mi
from
Atlanta, GA
Click here to add this to my saved trials
345 St Paul Pl
Baltimore, Maryland 21202
(410) 332-9000
Mercy Medical Center "Mercy Medical Center" is a hospital located in Baltimore, Maryland. The landmark...
1149
mi
from
Baltimore, MD
Click here to add this to my saved trials
303 East Superior Street
Chicago, Illinois 60611
611
mi
from
Chicago, IL
Click here to add this to my saved trials
Dallas, Texas 75203
350
mi
from
Dallas, TX
Click here to add this to my saved trials
Denver, Colorado 80210
407
mi
from
Denver, CO
Click here to add this to my saved trials
Detroit, Michigan 48202
841
mi
from
Detroit, MI
Click here to add this to my saved trials
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
1052
mi
from
Durham, NC
Click here to add this to my saved trials
Fairfax, Virginia 22031
1114
mi
from
Fairfax, VA
Click here to add this to my saved trials
Falls Church, Virginia 22042
1119
mi
from
Falls Church, VA
Click here to add this to my saved trials
Fayetteville, North Carolina 28304
1063
mi
from
Fayetteville, NC
Click here to add this to my saved trials
?
mi
from
Gainesville, FL
Click here to add this to my saved trials
Germantown, Tennessee 38138
481
mi
from
Germantown, TN
Click here to add this to my saved trials
Hillsborough, New Jersey 08844
1251
mi
from
Hillsborough, NJ
Click here to add this to my saved trials
646
mi
from
Indianapolis, IN
Click here to add this to my saved trials
340 W 10th St #6200
Indianapolis, Indiana 46202
(317) 274-3772
Indiana University School of Medicine With more than 2,000 students in 2013, the Indiana University...
643
mi
from
Indianapolis, IN
Click here to add this to my saved trials
La Jolla, California 92093
1142
mi
from
La Jolla, CA
Click here to add this to my saved trials
1118
mi
from
La Jolla, CA
Click here to add this to my saved trials
Lake Success, New York 11041
1302
mi
from
Lake Success, NY
Click here to add this to my saved trials
Long Beach, California 90822
1167
mi
from
Long Beach, CA
Click here to add this to my saved trials
Los Angeles, California 90027
1168
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Los Angeles, California 90036
1174
mi
from
Los Angeles, CA
Click here to add this to my saved trials
Marietta, Georgia 30060
788
mi
from
Marietta, GA
Click here to add this to my saved trials
Nashville, Tennessee 37211
619
mi
from
Nashville, TN
Click here to add this to my saved trials
1289
mi
from
New York, NY
Click here to add this to my saved trials
Newport News, Virginia 23602
1167
mi
from
Newport News, VA
Click here to add this to my saved trials
Norfolk, Virginia 23502
1186
mi
from
Norfolk, VA
Click here to add this to my saved trials
1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
1142
mi
from
Orlando, FL
Click here to add this to my saved trials
1161
mi
from
Pasadena, CA
Click here to add this to my saved trials
Philadelphia, Pennsylvania 19104
1223
mi
from
Philadelphia, PA
Click here to add this to my saved trials
Pittsburgh, Pennsylvania 15240
970
mi
from
Pittsburgh, PA
Click here to add this to my saved trials
Providence, Rhode Island 02905
1424
mi
from
Providence, RI
Click here to add this to my saved trials
575
mi
from
San Antonio, TX
Click here to add this to my saved trials
San Diego, California 92120
1139
mi
from
San Diego, CA
Click here to add this to my saved trials
San Diego, California 92123
1139
mi
from
San Diego, CA
Click here to add this to my saved trials
San Francisco, California 94080
1341
mi
from
San Francisco, CA
Click here to add this to my saved trials
Santa Fe, New Mexico 87505
475
mi
from
Santa Fe, NM
Click here to add this to my saved trials
299 Avenida José de Diego
Santurce, 00909
2331
mi
from
Santurce,
Click here to add this to my saved trials
Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
1410
mi
from
Seattle, WA
Click here to add this to my saved trials
1277
mi
from
Wellington, FL
Click here to add this to my saved trials
Winston-salem, North Carolina 27103
971
mi
from
Winston-salem, NC
Click here to add this to my saved trials