Last updated on April 2019

Efficacy and Safety of Switching From TDF to TAF in Adults With Chronic Hepatitis B Who Are Virologically Suppressed

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions: Chronic Hepatitis B
  • Age: Between 18 - 100 Years
  • Gender: Male or Female
  • Other:
    Key Inclusion Criteria:
    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 HBV infection previously
    Maintained on TDF 300 mg QD for at least 48 weeks, and as monotherapy for chronic
    hepatitis B for at least 24 weeks with viral suppression (HBV DNA < LLOQ) for a
    minimum of 12 weeks prior to screening
    Adequate renal function
    Normal ECG
    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 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 ALT > 5 × upper limit of the normal range
    Albumin < 3.0 mg/ dL
    International normalized ratio (INR) > 1.5 × ULN (unless stable on anticoagulant
    Total bilirubin > 2.5 × ULN
    Received solid organ or bone marrow transplant
    Malignancy within 5 years prior to screening, with the exception of specific cancers
    that are cured by surgical resection (eg, basal cell skin cancer). Individuals under
    evaluation for possible malignancy are not eligible.
    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 tenofovir
    alafenamide or tenofovir disoproxil fumarate 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
    Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Recruitment Status: Closed

Brief Description Eligibility Contact Research Team

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