EUCTR2005-004096-37-IT进行中（未招募）不适用
A phase 2, double-blind, multicenter, randomized study comparing tenofovir disoproxil fumarate, emtricitabine plus tenofovir disoproxil fumarate, and entecavir in the treatment of chronic hepatitis B subjects with decompensated liver disease and in the prevention of hepatitis B recurrence post-transplantation
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
- •-Seruma HBV DNA >=100000 copie/mL -Child-Pugh-Turcotte (CPT) score of 7-12 8inclusive) -Serum ALT < 10X ULN -Calculated creatinine clearance (Cockcroft-Gault) >= 50 mL/min - Hemoglobin >= 7.5 g/dL - alpha-fetoprotein (AFP)<=20 ng/mL and ultrasound or other imaging with no evidence of HCC, or alpha-fetoprotein of 21-50 ng/mL and CT/MRI with no evidence of HCC, within 3 months of screening.
- •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
- •- Pregnancy or breast-feeding - Solid organ or bone marrow transplant - Prior use of tenofovir DF or entecavir
研究者
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