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

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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
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...
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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330 Brookline Ave
Boston, Massachusetts 02215
617-667-7000
Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
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Jacksonville, FL
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2010 Wilshire Boulevard
Los Angeles, California 90057
213-413-2500
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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...
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Miami, Florida 33124
(305) 284-2211
University of Miami A private research university with more than 15,000 students from around the...
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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,...
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Arlington, Texas 76012
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Asheville, North Carolina 28801
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Atlanta, GA
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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...
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303 East Superior Street
Chicago, Illinois 60611
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Dallas, Texas 75203
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Denver, Colorado 80210
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Detroit, Michigan 48202
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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...
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Fairfax, Virginia 22031
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Falls Church, Virginia 22042
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Fayetteville, North Carolina 28304
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Germantown, Tennessee 38138
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Hillsborough, New Jersey 08844
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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...
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La Jolla, California 92093
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Lake Success, New York 11041
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Long Beach, California 90822
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Los Angeles, California 90027
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Los Angeles, California 90036
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Marietta, Georgia 30060
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Nashville, Tennessee 37211
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Newport News, Virginia 23602
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Norfolk, Virginia 23502
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1701 North Mills Avenue
Orlando, Florida 32803
(407)647-3960
Orlando Immunology Center Orlando Immunology Center , or simply (OIC) is a part of Infectious...
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Philadelphia, Pennsylvania 19104
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Pittsburgh, Pennsylvania 15213
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Pittsburgh, Pennsylvania 15240
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Providence, Rhode Island 02905
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San Antonio, TX
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San Diego, California 92120
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San Diego, California 92123
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San Francisco, California 94080
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Santa Fe, New Mexico 87505
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299 Avenida José de Diego
Santurce, 00909
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Winston-salem, North Carolina 27103
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