NL-OMON39436已完成4 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) - Not applicable
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Adult subjects (aged 18-75) with CHB (e.g., positive for either serum HBsAg or HBV DNA for at least 6 months) prior to baseline.;Anti-HBV treatment naïve subjects and subjects who have taken oral anti-HBV nucleoside therapy with the last dose greater than or equal to 24 weeks prior to screening are also eligible.;HBV DNA for HBeAg- >= 2000 IU/ml, and HBeAg+ subjects >= 20000 IU/ml.;ALT > 54 U/L and <= 400 U/L for men, and > 36 U/L and <= 300 U/L for women.;Creatinine clearance rate greater than or equal to 80 mL/min
排除标准
- •Known bridging fibrosis or cirrhosis and/or decompensated liver disease;Decompensated liver disease;Absolute neutrophil count < 1,500/mm3, platelet < 100,000/mm3, hemoglobin < 10 g/dL (female) or < 11 g/dL (male).;Evidence of hepatocellular carcinoma;Histroy of significant renal, cardiovascular, pulmonary, neurological, autoimmune disease or bone disease (e.g., osteomalacia,chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses, multiple bone fractures);History of severe depression or severe psychiatric disease;Thyroid dysfunction;Co-infection with HIV, HCV or HDV
研究者
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