jRCT2031230267进行中（未招募）不适用
A Phase III b, single-arm, multicenter, optimal dose finding study to assess the efficacy and safety of P1101 in Japanese patients with polycythemia vera (PV).
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 主要终点
- the rate of phlebotomy-free complete hematologic response (CHR)
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
- Treatment Purpose
- 盲法
- Open(masking Not Used)
入排标准
- 年龄范围
- 18age old over 至 No limit（—）
- 性别
- All
入选标准
- •Male or female patients >=18 years old at the time of informed consent to participate in the study
- •Patients diagnosed with PV according to the WHO 2008 or 2016 criteria
- •Patients with PV who have the inadequate response to an existing therapy or whom the existing therapy is inappropriate to apply
- •Patients who have given written informed consent to participate in this study
排除标准
- •Any contraindications to interferon alfa or hypersensitivity to interferon alfa
- •Subjects who stopped prior to interferon alfa therapy due to low efficacy or poor tolerability
- •Subjects with severe or serious diseases that the Investigator determines may affect the subject's participation in this study
- •History of major organ transplantation
- •Pregnant or breastfeeding women
结局指标
主要结局
the rate of phlebotomy-free complete hematologic response (CHR)
时间窗: Week 24
The percentage of patients who have a CHR and have not required phlebotomy in the previous 12 weeks. A responder for the primary endpoint is defined as a patient who meets all of the following criteria at Week 24: - Hct <45% and did not require phlebotomy (no phlebotomy was performed in the previous 12 weeks) - PLT =<400 x 10^9/L - WBC =<10 x 10^9/L
次要结局
- Time to achieve CHR
- Time to reach response maintenance dose
- Numbers of phlebotomy required and changes in numbers of phlebotomy required from baseline
- Time to first response in peripheral blood count
- Rate of achieving phlebotomy-free complete hematologic response (CHR)(Week 12 and Week 24)
- Duration of response in peripheral blood count
- Duration of response maintenance on peripheral blood count(Week 12 through Week 24)
- Improvement of symptoms assessed by MPN-SAF TSS(each visit)
- Proportion of subjects without thrombotic or hemorrhagic events(Weeks 12 and 24)
- Change from baseline to Week 24 in JAK2 V617F allele burden level(baseline to Week 24)
- Pharmacokinetics (PK) assessment
研究者
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