jRCT2051210083已完成不适用
Phase I, Open-Label, Multicentre, Dose-Escalation Study to Evaluate the Safety and Pharmacokinetics of A Single Intravenous PPMX-T003 in Polycythemia Vera
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 6
- 主要终点
- Number of patients Experiencing Treatment-emergent Adverse Events (TEAEs)
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Single Arm Study
- 干预模型
- Single Assignment
- 主要目的
- Other
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 20age old over 至 75age old not（—）
- 性别
- All
入选标准
- •Confirmed diagnosis of PV according to either the 2008 or 2016 WHO classification criteria
- •PV patients being only treated with phlebotomy and the interval is 4-9 weeks
排除标准
- •Patients administrated drugs for PV treatment such as hydroxyurea or ruxolitinib (aspirin is excluded)
结局指标
主要结局
Number of patients Experiencing Treatment-emergent Adverse Events (TEAEs)
Evaluation based on: - Vital signs - Laboratory test values - Standard 12-lead ECG - Physical findings
次要结局
- Pharmacokinetics
- Immunogenicity
- Pharmacodynamics
研究者
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