A Randomized, Double-Blind, Controlled Evaluation of Tenofovir DF versus Adefovir Dipivoxil for the Treatment of HBeAg Positive Chronic Hepatitis B

Gilead Sciences Incorporated0 个研究点目标入组 240 人开始时间: 2005年6月15日最近更新: 2016年11月14日

适应症

试验速览

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•1) Chronic HBV infection, defined as positive serum HBsAg for more than 6 months.
•2) 18 through 69 years of age, inclusive.
•3) Active HBeAg positive chronic HBV infection, with all of the following:
•HBeAg positive at screening
•ALT levels > 2 x ULN and = 10 x ULN
•Serum HBV DNA >1000000 copies/mL at screening
•creatinine clearance = 70 mL/min
•hemoglobin = 8 g/dL
•neutrophils = 1,000 /mm3
•4) Knodell necroinflammatory score = 3 and a Knodell fibrosis score < 4. However, up to 96 patients with cirrhosis, i.e., a Knodell fibrosis score equal to 4, will be eligible for enrollment.
•5) Negative serum ß-HCG
•6) Nucleotide naïve, i.e., no prior nucleotide (tenofovir DF or adefovir dipivoxil) therapy for greater than 12 weeks.
•7) Nucleoside naïve, i.e., no prior nucleoside (any nucleoside) therapy for greater than 12 weeks.
•8) Willing and able to provide written informed consent.
•9) Had a liver biopsy performed within 6 months of baseline and has readable biopsy slides or agrees to have a biopsy performed prior to baseline.
•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 228
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 12

•1) Pregnant women, women who are breast feeding or who believe they may wish to become pregnant during the course of the study.
•2) Males and females of reproductive potential who are unwilling to use an effective” method of contraception during the study. For males, condoms should be used and for females, a barrier contraception method should be used.
•3) Decompensated liver disease defined as conjugated bilirubin >1.5 x ULN, 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).
•4) Received any nucleoside, nucleotide (tenofovir DF or adefovir dipivoxil) or interferon (pegylated or not) therapy within 6 months prior of the pre-treatment biopsy.
•5) Evidence of hepatocellular carcinoma (HCC), for example, a fetoprotein > 50 ng/mL or by any other standard of care measure.
•6) Co-infection with HCV, HIV, or HDV.
•7) Significant renal, cardiovascular, pulmonary, or neurological disease.
•8) Received solid organ or bone marrow transplantation.
•9) Is currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, or agents susceptible of modifying renal excretion.
•10) Has proximal tubulopathy.
•11) Known hypersensitivity to the study drugs, the metabolites or formulation excipients.

发起方

Gilead Sciences Incorporated