EUCTR2010-024586-45-DE进行中（未招募）不适用
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
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
- 720
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
- •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 = 24 weeks prior to screening are also eligible.
- •HBV DNA = 20,000 IU/ml for HBeAg+ subjects and HBV DNA = 2,000 IU/ml for HBeAg- subjects
- •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
- •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 706
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 14
排除标准
- •Known bridging fibrosis or cirrhosis and/or decompensated liver disease
- •Decompensated liver disease
- •Absolute neutrophil count < 1,500/mm^3, platelet < 100,000/mm^3, 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
- •Ongoing therapy with any of the following:
- •Nephrotoxic agents
- •— Parenteral aminoglycoside antibiotics (e.g., gentamicin, tobramycin, amikacin)
- •— Cidofovir
- •— Cisplatin
- •— Foscarnet
- •— IV amphotericin B
- •— IV pentamidine
- •— Oral or IV ganciclovir
- •— Cyclosporine
- •— Tacrolimus
- •— IV vancomycin
- •— Chronic daily non-steroidal anti-inflammatory drug therapy
- •Hepatotoxic agents such as anabolic steroids, isoniazid, itraconazole, ketoconazole, rifabutin, rifampin and other agents with significant hepatotoxic potential
- •Competitors of renal excretion (e.g., probenecid)
- •Systemic chemotherapeutic agents
- •Systemic corticosteroids
- •Interleukin-2 (IL-2) and other immunomodulating agents
- •Investigational agents (except with the expressed approval of the Sponsor)
- •Administration of any of the above mentioned medications must be discontinued at least 30 days prior to the Baseline Visit and for the duration of the study period.
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