EUCTR2010-024586-45-FR进行中（未招募）1 期
A Phase 4, Randomized, Open-label, Active-Controlled, Superiority Study to Evaluate the Efficacy and Safety of Tenofovir Disoproxil Fumarate (TDF) in Combination with Peginterferon a-2a (Pegasys®) versus Standard of Care Tenofovir Disoproxil Fumarate Monotherapy or Peginterferon a-2a Monotherapy for 48 Weeks in Non-Cirrhotic Subjects with HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B (CHB).
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 751
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
- •Anti-HBV treatment naïve adult subjects (Subjects who have taken less than 12 weeks of oral anti-HBV nucleoside therapy with the last dose greater than or equal to 24 weeks prior to screening are also eligible).
- •HBV DNA > 10^5 copies/mL for HBeAg- and > 10^6 copies/mL for HBeAg+ subjects
- •ALT > 2x ULN < 10x ULN
- •Creatinine clearance rate greater than or equal to 70 mL/min
- •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
排除标准
- •Known cirrhosis and/or decompensated liver disease
- •Evidence of hepatocellular carcinoma
- •Significant renal, cardiovascular, pulmonary, neurological, autoimmune disease or bone disease (e.g., osteomalacia,chronic osteomyelitis, osteogenesis imperfecta,
- •osteochrondroses, multiple bone fractures)
- •Absolute neutrophil count < 1,500/mm^3, platelet < 100,000/mm^3, hemoglobin < 10 g/dL (female) or < 11 g/dL (male)
- •History of depression or psychiatric disease
- •Thyroid dysfunction
- •Co-infection with HIV, HCV or HDV
研究者
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