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
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