A Phase 3b, Randomized, Double-Blind, Double-Dummy Study Evaluating the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects with Chronic Hepatitis B who are Resistant to Lamivudine - Not applicable

Gilead Sciences Inc0 个研究点目标入组 250 人开始时间: 2008年8月27日最近更新: 2015年7月10日

试验速览

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•Chronic HBV infection, defined as positive serum HBsAg for at least 6 months
•Males and females, 18 through 75 years of age, inclusive. In Greece, only postmenopausal and/or surgically sterile women may participate.
•HBV DNA = 10^3 copies/mL
•Currently receiving lamivudine with confirmation of HBV reverse transcriptase mutation(s) known to confer resistance to lamivudine (rtM204I/V with or without rtL180M) by central laboratory assessment prior to randomization.
•Prior or current adefovir dipivoxil treatment of = 48 weeks at the time of screening (inclusive of combination adefovir dipivoxil + lamivudine at entry) is allowed
•Willing and able to provide written informed consent
•Negative serum ß-HCG (for females of childbearing potential only), although in
•Greece only post-menopausal and/or surgically sterile women may participate.
•Calculated creatinine clearance = 50 mL/min
•Hemoglobin = 10 g/dL
•Neutrophils = 1,000 /mm3
•No prior oral HBV therapy with approved nucleotide and/or nucleoside therapy or other investigational agents for HBV infection other than lamivudine or adefovir dipivoxil.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 239
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 41

•Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study.
•Males of reproductive potential who are not willing to use an effective” method of contraception during the study. This should be, at minimum, a condom. In Greece, only postmenopausal and/or surgically sterile women may participate.
•ALT = 10 × ULN
•Decompensated liver disease defined as direct (conjugated) bilirubin > 1.5 x ULN, prothrombin time (PT) > 1.5 x ULN, platelets < 75,000/mm3, serum albumin < 3.0 g/dL, or prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy, variceal hemorrhage).
•Received interferon (pegylated or not) therapy within 6 months of the screening visit
•a -fetoprotein > 50 ng/mL
•Evidence of HCC
•Co infection with HCV (by serology), HIV, or HDV
•Significant renal, cardiovascular, pulmonary, or neurological disease
•Received solid organ or bone marrow transplantation
•Is currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion
•Has proximal tubulopathy
•Known hypersensitivity to the study drugs, the metabolites or formulation excipients

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