Phase
Condition
Hepatitis
Liver Disorders
Hepatitis B
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
Must have the ability to understand and sign a written informed consent form; consentmust be obtained prior to initiation of study procedures
Adult male and non-pregnant, non-lactating females
Documented evidence of chronic hepatitis B virus (HBV) infection previously
Maintained on tenofovir disoproxil fumarate (TDF) 300 mg once daily for at least 48weeks, and as monotherapy for chronic hepatitis B for at least 24 weeks with viralsuppression (HBV DNA < lower limit of quantitation) for a minimum of 12 weeks prior toscreening
Adequate renal function
Normal Electrocardiogram
Exclusion
Key Exclusion Criteria:
Pregnant women or women who are breastfeeding
Males and females of reproductive potential who are unwilling to use an "effective",protocol-specified method(s) of contraception during the study.
Co-infection with hepatitis C virus (HCV), hepatitis D virus (HDV), or humanimmunodeficiency virus (HIV)
Evidence of hepatocellular carcinoma
Current evidence of, or recent (≤ 5 year) history of clinical hepatic decompensation
Abnormal hematological and biochemical parameters, including:
Hemoglobin < 10 g/dL
Absolute neutrophil count < 750/mm^3
Platelets ≤ 50,000/mm^3
Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 5 × upperlimit of the normal (ULN)
Albumin < 3.0 mg/ dL
International normalized ratio (INR) > 1.5 × ULN (unless stable on anticoagulantregimen)
Total bilirubin > 2.5 × ULN
Received solid organ or bone marrow transplant
Malignancy within 5 years prior to screening, with the exception of specific cancersthat are cured by surgical resection (eg, basal cell skin cancer). Individuals underevaluation for possible malignancy are not eligible.
Currently receiving therapy with immunomodulators (eg, corticosteroids), nephrotoxicagents, or agents capable of modifying renal excretion
Individuals receiving ongoing therapy with drugs not to be used with TAF or TDF orindividuals with a known hypersensitivity to study drugs, metabolites, or formulationexcipients
Current alcohol or substance abuse judged by the investigator to potentially interferewith compliance
Any other clinical condition or prior therapy that, in the opinion of theinvestigator, would make the individual unsuitable for the study or unable to complywith dosing requirements.
Use of investigational agents within 3 months of screening, unless allowed by thesponsor Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study Design
Connect with a study center
Edmonton,
CanadaSite Not Available
Toronto,
CanadaSite Not Available
Vancouver,
CanadaSite Not Available
Hong Kong,
Hong KongSite Not Available
Kowloon,
Hong KongSite Not Available
Milan, 20122
ItalySite Not Available
Goyang, Gyeonggi-d
Korea, Republic ofSite Not Available
Daegu, 700-721
Korea, Republic ofSite Not Available
empty
Goyang-si, 411-706
Korea, Republic ofSite Not Available
Seoul, 152-703
Korea, Republic ofSite Not Available
Barcelona,
SpainSite Not Available
Majadahonda,
SpainSite Not Available
Chiayi City, 60002
TaiwanSite Not Available
Kaohsiung,
TaiwanSite Not Available
Taipei City, 10002
TaiwanSite Not Available
London,
United KingdomSite Not Available
Los Angeles, California
United StatesSite Not Available
Palo Alto, California
United StatesSite Not Available
Pasadena, California
United StatesSite Not Available
San Diego, California
United StatesSite Not Available
San Francisco, California
United StatesSite Not Available
San Jose, California
United StatesSite Not Available
Baltimore, Maryland
United StatesSite Not Available
Boston, Massachusetts
United StatesSite Not Available
Novi, Michigan
United StatesSite Not Available
Flushing, New York 11355
United StatesSite Not Available
New York, New York
United StatesSite Not Available
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Nashville, Tennessee
United StatesSite Not Available
Sugar Land, Texas 77478
United StatesSite Not Available
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