NCT00907894已完成1 期
A Phase I, Open-Label, Single-Dose Study to Evaluate the Pharmacokinetics and Safety of Telbivudine (LDT600) in Children and Adolescents With Chronic Hepatitis B
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- LDT600 plasma concentration and pharmacokinetic (PK) parameters of exposure (Cmax and AUC)
研究概览
简要总结
This is a Phase I, open-label, single-dose study to evaluate the pharmacokinetics and safety of LDT600 in pediatric and adolescent patients with chronic hepatitis B infection.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children and adolescents patients
- •HBsAg seropositive
- •Exclusion criteria:
- •Decompensated liver disease (Child-Turcotte-Pugh (CTP) Score≥7, Class B and C)
- •Prior anti-HBV therapy within 30 days of study drug dosing.
- •Other protocol-defined inclusion/exclusion criteria may apply.
排除标准
- 未提供
研究组 & 干预措施
Stratum 1
Experimental
干预措施: LDT600 (Telbivudine) (Drug)
Stratum 2
Experimental
干预措施: LDT600 (Telbivudine) (Drug)
Stratum 3
Experimental
干预措施: LDT600 (Telbivudine) (Drug)
结局指标
主要结局
LDT600 plasma concentration and pharmacokinetic (PK) parameters of exposure (Cmax and AUC)
时间窗: 6 days
To evaluate the single-dose pharmacokinetics of LDT600 in pediatric and adolescent patients (2-18 years of age) with chronic hepatitis B (CHB) infection.
次要结局
- Safety assessments will include vital signs, ECG and incidence of adverse events and serious adverse events.(6 days)
研究者
研究点 (2)
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