Sofosbuvir/Velpatasvir Fixed-Dose Combination in Adults With Chronic HCV Infection



Status:Completed
Conditions:Infectious Disease, Infectious Disease, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:11/18/2018
Start Date:February 23, 2015
End Date:June 15, 2016

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An Open Label Study of Sofosbuvir/GS-5816 Fixed-Dose Combination in Subjects With Chronic HCV Infection

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability
of treatment with sofosbuvir/velpatasvir (SOF/VEL) in participants with chronic genotype 1,
2, 4, 6 or indeterminate HCV infection who received placebo in the Gilead-sponsored study
GS-US-342-1138.


Key Inclusion Criteria:

- Willing and able to provide written informed consent

- Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy

- Was administered placebo to match SOF/VEL in Gilead study GS-US-342-1138

- HCV RNA ≥ 10^4 IU/mL at screening

- Classification as treatment naive or treatment experienced

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

Key Exclusion Criteria:

- Current or prior history of clinically-significant illness (other than HCV) or any
other major medical disorder that may interfere with treatment, assessment, or
compliance with the protocol; individuals currently under evaluation for a potentially
clinically-significant illness (other than HCV) are also excluded.

- Screening electrocardiogram (ECG) with clinically significant abnormalities

- Laboratory results outside of acceptable ranges at screening

- Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A
inhibitor

- 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
22
sites
1908
mi
from 91732
Marietta, GA
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5586
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from 91732
Antwerp,
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1919
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from 91732
Atlanta, GA
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825
mi
from 91732
Aurora, CO
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2301
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from 91732
Baltimore, MD
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2578
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from 91732
Boston, MA
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2103
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from 91732
Gainesville, FL
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1600
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from 91732
Germantown, TN
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1793
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from 91732
Indianapolis, IN
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2127
mi
from 91732
Jacksonville, FL
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21
mi
from 91732
Long Beach, CA
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13
mi
from 91732
Los Angeles, CA
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2321
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from 91732
Miami, FL
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1763
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from 91732
Nashville, TN
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329
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from 91732
Palo Alto, CA
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2375
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from 91732
Philadelphia, PA
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2119
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from 91732
Pittsburgh, PA
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2562
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from 91732
Providence, RI
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2267
mi
from 91732
Richmond, VA
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364
mi
from 91732
Sacramento, CA
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105
mi
from 91732
San Diego, CA
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2294
mi
from 91732
Wellington, FL
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