NCT00724776已完成1 期
A Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Escalating Single Dose of Albinterferon Alfa 2b (Alb-IFN), Recombinant Human Albumin-interferon Alfa Fusion Protein in Japanese Chronic Hepatitis C Patients.
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Safety and tolerability after single dose
研究概览
简要总结
This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of albinterferon alfa 2b (alb-IFN) single dose in Japanese chronic hepatitis C patients
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a clinical diagnosis of CHC established on the basis of a detectable viral load as measured by a serum HCV RNA test at least 6 months before and during the screening period.
- •Age 20 to 69 years
- •Have compensated liver disease results on screening laboratory assessment
排除标准
- •Evidence of decompensated liver disease and/or liver cirrhosis.
- •Body weight < 50 kg.
- •A history of immunologically mediated disease.
- •A history or other clinical evidence of interstitial lung disease
结局指标
主要结局
Safety and tolerability after single dose
时间窗: 5 weeks after single dose
次要结局
- Pharmacokinetics of albinterferon alfa 2b HCV RNA and ALT as pharmacodynamics evaluation(5 weeks after single dose)
研究者
研究点 (1)
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