EUCTR2007-001789-34-IT进行中（未招募）不适用
A multicenter open label study to explore the efficacy and tolerability of Tenofovir DF (TDF) (300 mg) in chronic hepatitis B, HBeAg positive or negative, patients with suboptimal response to adefovir (ADV) or ADV/LAM treatment, defined as HBV-DNA levels > 10.000 copies/ml after an ADV or ADV+LAM treatment of > 48 weeks - OptiB: Optimizing treatment for Chronic Hepatitis B patients
AZIENDA UNIVERSITARIA POLICLINICO UMBERTO I DI ROMA0 个研究点开始时间: 2008年1月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •?> 18 years of age
- •?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 or the combination of adefovir dipivoxil 10 mg QD and lamivudine 100 mg QD (for 48 weeks)
- •HBeAg+ve or anti-HBe+ve at screening
- •Serum HBV DNA 104 copies/mL
- •Serum ALT 20 ULN
- •Hemoglobin 8 g/dL
- •Neutrophils 750 /mm3
- •?Adefovir or lamivudine-experienced
- •?Negative serum -HCG
- •?Compliant with adefovir dipivoxil
- •?Willing and able to provide written informed consent
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •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
排除标准
- •?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 put into action all necessary steps to avoid pregnancy while enrolled in the study.
- •?Prior use of tenofovir DF or entecavir
- •?Received treatment with interferon or pegylated interferon within 6 months of the screening visit.
- •?Co-infection with HCV (based on serology), HIV, or HDV.
- •?Significant renal, cardiovascular, pulmonary, or neurological disease.
- •?Received solid organ or bone marrow transplantation.
- •?Currently receiving therapy with immunomodulators (e.g., corticosteroids, etc.), investigational agents, nephrotoxic agents, agents capable of modifying renal excretion.
- •?Proximal tubulopathy
- •?Known hypersensitivity to the study drugs (tenofovir DF or emtricitabine/tenofovir DF), the metabolites (tenofovir or emtricitabine) or formulation excipients.
研究者
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