Safety and Efficacy of Voxilaprevir Plus Sofosbuvir/Velpatasvir Fixed Dose Combination in Adults With Chronic Non-Genotype 1 HCV Infection



Status:Completed
Conditions:Infectious Disease, Infectious Disease, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:2/27/2019
Start Date:February 16, 2015
End Date:January 26, 2016

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A Phase 2, Global, Multicenter, Open-Label Study to Investigate the Safety and Efficacy of GS-9857 Plus Sofosbuvir/GS-5816 Fixed Dose Combination in Subjects With Chronic Non-Genotype 1 HCV Infection

The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of
voxilaprevir (VOX) plus sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) in
adults with chronic non genotype 1 hepatitis C virus (HCV) infection.


Key Inclusion Criteria:

- Individuals with chronic HCV infection

- HCV RNA ≥10^4 IU/mL at screening

- HCV genotypes 2, 3, 4, 5, or 6

- Cirrhosis determination; a liver biopsy may be required

- Screening laboratory values within defined thresholds

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

Key Exclusion Criteria:

- Pregnant or nursing female

- Current or prior history of hepatic decompensation

- Hepatocellular carcinoma (HCC) or other clinically significant malignancy

- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

- History of clinically significant illness or any other medical disorder that may
interfere with the individual's treatment, assessment or compliance with the protocol

NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
32
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Aurora, Colorado 80045
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185 Cambridge Street
Boston, Massachusetts 02114
617-724-5200
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5801 South Ellis Avenue
Chicago, Illinois 60637
 773.702.1234
University of Chicago One of the world's premier academic and research institutions, the University of...
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4800 Belfort Rd # 2
Jacksonville, Florida 32256
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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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Los Angeles, CA
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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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Atlanta, GA
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Boston, Massachusetts
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
Medical University of South Carolina The Medical University of South Carolina (MUSC) has grown from...
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31 Tuam Street
Christchurch, 8011
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Detroit, Michigan 48202
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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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Indianapolis, IN
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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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Manhasset, NY
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Marietta, Georgia 30060
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Nashville, Tennessee 37211
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New York, New York 10003
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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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Palo Alto, California 94304
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Philadelphia, Pennsylvania
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Pittsburgh, Pennsylvania 15213
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Richmond, Virginia 23226
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San Antonio, Texas 78215
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San Diego, California 92123
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Santa Fe, New Mexico 87505
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Seattle, Washington
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Winston-salem, North Carolina 27103
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