Study to Compare Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF) in Participants With Chronic Hepatitis B Infection Who Are Negative for Hepatitis B e Antigen
Trial ID or NCT#
The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis B e antigen (HBeAg)-negative chronic hepatitis B virus (HBV) infection.
A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD Versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Negative, Chronic Hepatitis B
- - Ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study procedures. - Adult males and non-pregnant, non-lactating females. - Documented evidence of chronic HBV infection. - Hepatitis e antigen (HBeAg)-negative, chronic hepatitis B with all of the following: - HBeAg-negative and hepatitis B e antibody (HBeAb) positive at screening. - Screening HBV DNA ≥ 2 x 10^4 IU/mL. - Screening serum alanine aminotransferase (ALT) level > 60 U/L (males) or > 38 U/L (females) and ≤ 10 x the upper limit of the normal range (ULN). - Treatment-naive participants (defined as < 12 weeks of oral antiviral treatment with any nucleoside or nucleotide analogue), OR treatment-experienced participants (defined as participants meeting all entry criteria [including HBV DNA and serum ALT criteria] and with ≥ 12 weeks of previous treatment with any nucleoside or nucleotide analogue). - Previous treatment with interferon (pegylated or non pegylated) must have ended at least 6 months prior to Baseline. - Adequate renal function. - Normal electrocardiogram (ECG). Key
- - Females 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, human immunodeficiency virus (HIV), or hepatitis D virus. - Evidence of hepatocellular carcinoma. - Any history of, or current evidence of, clinical hepatic decompensation. - Abnormal hematological and biochemical parameters, including aspartate aminotransferase (AST) > 10 x ULN - Received solid organ or bone marrow transplant. - History of malignancy within the past 5 years, with the exception of specific cancers that are cured by surgical resection; individuals under evaluation for possible malignancy are not eligible. - Currently receiving therapy with immunomodulators (eg, corticosteroids), investigational agents, 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 participant compliance. - Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the participant unsuitable for the study or unable to comply with dosing requirements. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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