Saves the questions and what to expect into your notes, next to the visit they belong to.
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; consent must 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 48 weeks, and as monotherapy for chronic hepatitis B for at least 24 weeks with viral suppression (HBV DNA \< lower limit of quantitation) for a minimum of 12 weeks prior to screening
Adequate renal function
Normal Electrocardiogram
You may not be if
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 human immunodeficiency 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 × upper limit of the normal (ULN)
* Albumin \< 3.0 mg/ dL
* International normalized ratio (INR) \> 1.5 × ULN (unless stable on anticoagulant regimen)
* Total bilirubin \> 2.5 × ULN
Received solid organ or bone marrow transplant
Currently receiving therapy with immunomodulators (eg, corticosteroids), nephrotoxic agents, or agents capable of modifying renal excretion
Individuals receiving ongoing therapy with drugs not to be used with TAF or TDF or individuals with a known hypersensitivity to study drugs, metabolites, or formulation excipients
Current alcohol or substance abuse judged by the investigator to potentially interfere with compliance
Any other clinical condition or prior therapy that, in the opinion of the investigator, would make the individual unsuitable for the study or unable to comply with dosing requirements.
Use of investigational agents within 3 months of screening, unless allowed by the sponsor
Clareo Health | Study to Evaluate Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed
