A Phase 2, Randomized, Double-Blind Study Exploring the Efficacy, Safety and Tolerability of Tenofovir Disoproxil Fumarate (DF) Monotherapy Versus Emtricitabine plus Tenofovir DF Fixed-Dose Combination Therapy in Subjects Currently Being Treated with Adefovir Dipivoxil for Chronic Hepatitis B and having Persistent Viral Replication.

Gilead Sciences Incorporated0 个研究点目标入组 90 人开始时间: 2005年12月27日最近更新: 2014年2月10日

试验速览

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•18 through 69 years of age, inclusive
•Chronic HBV infection, defined as positive serum HBsAg for at least 6 months
•Active chronic HBV infection with all the following:
•- Currently treated with adefovir dipivoxil 10 mg QD (for = 24 weeks but = 96 weeks)
•- HBeAg positive or negative at screening
•- Plasma HBV DNA = 1000 copies/mL at screening (irrespective of HBeAg status)
•- Serum ALT < 10 x ULN
•- Creatinine clearance = 70 mL/min
•- Hemoglobin = 8 g/dL
•- Neutrophils = 1,000 /mm3
•Nucleoside-naïve or lamivudine-experienced (= 12 weeks of therapy)
•Negative serum ß-HCG
•Compliant with adefovir dipivoxil
•Willing and able to provide written informed consent (Note: individuals who have been committed to an institution by virtue of an order issued either by the courts or by a public authority will not be enrolled in this study).
•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
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range

•Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study.
•Male or females of reproductive potential who are unwilling to use an effective method of contraceptive while enrolled in the study. For males, condoms should be used and for females, a barrier contraception method should be used.
•Decompensated liver disease defined as 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).
•Prior use of tenofovir DF or entecavir
•Received treatment with interferon or pegylated interferon within 6 months of the screening visit.
•Evidence of HCC; for example, a fetoprotein > 50 ng/mL or by any other standard of care measure.
•Co-infection with HCV (based on 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 capable of modifying renal excretion.
•Has proximal tubulopathy
•Known hypersensitivity to tenofovir DF or emtricitabine/tenofovir DF, tenofovir or emtricitabine or their phosphorylated forms, or study drug product formulation excipients.

发起方

Gilead Sciences Incorporated