EUCTR2016-001444-20-Outside-EU/EEA进行中（未招募）1 期
An Open-label, Single-arm, Multicenter, Phase IV, 52-week Study to Evaluate the Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients with Chronic Hepatitis B
Beijing Novartis Pharma Co., Ltd.0 个研究点目标入组 2,211 人开始时间: 2016年5月18日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,211
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
- •Male or female 16 to 65 year of age
- •Documented CHB defined by detectable serum HBsAg and serum HBV DNA level
- •Willing and able to comply with the study drug regimen
- •Written informed consent before any assessment
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 26
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 2153
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 2
排除标准
- •Patient has a history of/or clinical signs/symptoms of hepatic decompensation
- •Patient has a history of HCC or findings suggestive of possible HCC
- •Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time
- •History of hypersensitivity to any of the drugs (telbivudine) or to drugs of similar clinical classes
- •Patient has received IFN or other immunomodulatory treatment with 12 months before screening
- •Previous treatment history with NRTIs
研究者
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