Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment
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Keep this study
Lead
Gilead Sciences
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study
Documented evidence of chronic hepatitis B virus (HBV) infection, for example, hepatitis B surface antigen (HBsAg) positive for more than 6 months
Screening HBV DNA ≥ 2000 IU/mL
A negative serum pregnancy test is required for females (unless surgically sterile or \> 2 years post-menopausal)
You may not be if
Cirrhosis
Inadequate liver function
Co-infection with hepatitis C virus (HCV), HIV or hepatitis D virus (HDV)
Received antiviral treatment for HBV within 3 months of screening
Evidence of hepatocellular carcinoma (eg, as evidenced by recent imaging)
Significant cardiovascular, pulmonary, or neurological disease
Women who are pregnant or may wish to become pregnant during the course of the study
Received solid organ or bone marrow transplant
Received prolonged therapy with immunomodulators (eg, corticosteroids) or biologics (eg, monoclonal antibody, interferon) within 3 months of screening
Use of investigational agents within 3 months of screening
Current alcohol or substance abuse judged by the investigator to potentially interfere with individual's compliance
Receipt of immunoglobulin or other blood products within 3 months prior to enrollment
History of demyelinating disease (Guillain-Barre), Bell's Palsy, Crohn's disease, Ulcerative colitis, or autoimmune disease
Documented history of yeast allergy
Known hypersensitivity to study drugs, metabolites or formulation excipients
Clareo Health | Safety and Efficacy of GS-4774 in Combination With Tenofovir Disoproxil Fumarate (TDF) for the Treatment of Participants With Chronic Hepatitis B (CHB) and Who Are Currently Not on Treatment
