Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-9857 in Subjects With Chronic Hepatitis C Virus Infection



Status:Completed
Conditions:Infectious Disease, Hepatitis, Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 65
Updated:4/21/2016
Start Date:June 2014
End Date:September 2015

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Phase 1b, Randomized, Double-Blind, Multiple-Dose Ranging Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Antiviral Activity of GS-9857 in Subjects With Chronic Hepatitis C Virus Infection

This study will evaluate the safety, tolerability, and antiviral activity of GS-9857 alone
or with sofosbuvir (SOF)/GS-5816 fixed dose combination (FDC) in adults with genotypes 1, 2,
3, or 4 hepatitis C virus (HCV) infection. All participants will be monitored for up to 48
weeks after the last dose to monitor for persistence of viral mutations.


Inclusion Criteria:

- Chronic genotype 1-4 HCV infection

- For Cohorts 1-9, HCV RNA ≥ 100,000 IU/mL at screening (no HCV RNA restriction for
Cohort 10)

- Screening laboratory values within defined thresholds

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

Exclusion Criteria:

- Pregnant or nursing female or male with pregnant female partner

- Presence of cirrhosis

- Prior exposure to approved or experimental HCV Protease Inhibitors

- Co-infection with HIV or hepatitis B virus (HBV)

- Current or prior history of clinical hepatic decompensation

- Chronic use of systemic immunosuppressive agents

- History of clinically significant illness or any other medical disorder that may
interfere with subject treatment, assessment or compliance with the protocol
We found this trial at
11
sites
2331
mi
from
San Juan,
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1237
mi
from
Berlin, NJ
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1158
mi
from
Costa Mesa, CA
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?
mi
from
DeLand, FL
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198
mi
from
Kansas City, MO
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779
mi
from
Knoxville, TN
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?
mi
from
Marlton, NJ
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1139
mi
from
Orlando, FL
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1225
mi
from
Philadelphia, PA
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418
mi
from
Saint Louis, MO
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583
mi
from
San Antonio, TX
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