A Study of the Safety, Tolerability, and Efficacy of Vesatolimod in Combination With Tenofovir Disoproxil Fumarate (TDF) in Adults With Chronic Hepatitis B (CHB) Infection Who Are Currently Not Being Treated



Status:Active, not recruiting
Conditions:Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 65
Updated:4/4/2019
Start Date:November 10, 2015
End Date:May 2019

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Trial Summary
Trial Overview
Inclusion Criteria

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Safety and Efficacy of GS-9620 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Subjects With Chronic Hepatitis B and Who Are Currently Not on Treatment

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy
of vesatolimod (formerly GS-9620) in adults with chronic hepatitis B (CHB) infection who are
currently not being treated.


Key Inclusion Criteria:

- Adult males or females between the ages of 18-65

- Chronic HBV infection

- HBV DNA ≥ 2000 IU/mL at screening

Key Exclusion Criteria:

- Extensive bridging fibrosis or cirrhosis

- Received oral antiviral treatment for HBV or prolonged therapy with immune-modulators
or biologics within 3 months of screening

- Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV)

- Chronic liver disease other than HBV

- Lactating or pregnant females or those that wish to become pregnant during the course
of the study

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
We found this trial at
10
sites
Clinical Trial Facility in Los Angeles California
Los Angeles, California
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Los Angeles, CA
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Clinical Trial Facility in Boston Massachusetts
Boston, Massachusetts
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Boston, MA
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Clinical Trial Facility in Catonsville Maryland
Catonsville, Maryland 21228
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Catonsville, MD
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Clinical Trial Facility in Flushing New York
Flushing, New York 11355
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Flushing, NY
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Clinical Trial Facility in Honolulu Hawaii
Honolulu, Hawaii
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Honolulu, HI
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Clinical Trial Facility in Palo Alto California
Palo Alto, California 94301
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Palo Alto, CA
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Clinical Trial Facility in Philadelphia Pennsylvania
Philadelphia, Pennsylvania
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Philadelphia, PA
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Clinical Trial Facility in San Diego California
San Diego, California
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San Diego, CA
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Clinical Trial Facility in San Francisco California
San Francisco, California
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San Francisco, CA
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Clinical Trial Facility in Toronto Ontario
Toronto, Ontario
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Toronto,
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