Safety and Efficacy of GS-4774 for the Treatment of Chronic Hepatitis B



Status:Completed
Conditions:Hepatitis, Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - 65
Updated:5/3/2014
Start Date:September 2013
End Date:March 2015

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A Phase 2, Randomized, Open-Label Study to Evaluate the Safety and Efficacy of GS-4774 for the Treatment of Virally-Suppressed Subjects With Chronic Hepatitis B

This is a randomized, open-label, multicenter Phase 2 study to evaluate the safety and
efficacy of GS-4774 in subjects with chronic hepatitis B (CHB) viral infection who have been
virally suppressed with an oral antiviral medication. One hundred and seventy-five subjects
will be randomized in a 1:2:2:2 ratio to the treatment arms for 20 weeks.


Inclusion Criteria:

- Ability to understand and sign a written informed consent form, which must be
obtained prior to initiation of study procedures

- Currently taking an HBV oral antiviral medication

- Documented evidence of chronic HBV infection (eg, HBsAg positive for more than 6
months)

- Virally-suppressed (HBV DNA below the lower limit of quantification [LLOQ] by for ≥ 1
year)

Exclusion Criteria:

- Cirrhosis

- Inadequate liver function

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

- Evidence of hepatocellular carcinoma

- Significant cardiovascular, pulmonary, or neurological disease

- Females who are pregnant or may wish to become pregnant during the study

- Received solid organ or bone marrow transplant

- Use of another investigational agents within 3 months of screening

- Current alcohol or substance abuse judged by the investigator to potentially
interfere with compliance

- History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease
ulcerative colitis, autoimmune disease

- Known hypersensitivity to study drug, metabolites or formulation excipients

- Malignancy within 5 years prior to screening, with the exception of specific cancers
that are cured by surgical resection (basal cell skin cancer, etc). Participants
under evaluation for possible malignancy are not eligible.
We found this trial at
16
sites
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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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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Boston, MA
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500 S State St
Ann Arbor, Michigan 48109
(734) 764-1817
University of Michigan The University of Michigan was founded in 1817 as one of the...
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Baltimore, Maryland 21229
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Baltimore, MD
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251 E Huron St
Chicago, Illinois 60611
(312) 926-2000
Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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Chicago, IL
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Detroit, Michigan 48202
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Flushing, New York 11355
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Los Angeles, California 90095
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Manhasset, New York 11030
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Newport News, Virginia 23602
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Pasadena, California 91105
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Sacramento, California 95825
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San Diego, California 92120
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San Francisco, California 94115
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San Jose, California 95128
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St. Louis, Missouri 63110
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St. Louis, MO
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