Extension Study of P1101 in Japanese Patients Who Have Completed Phase 2 Single Arm Study in Polycythemia Vera (PV) Patients (Study A19-201) or Phase 3 Study in Essential Thrombocythemia (ET) Patients (Study P1101 ET)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 67
- 试验地点
- 6
- 主要终点
- Maintenance rate of phlebotomy-free complete hematologic response (CHR) every 52 weeks
研究概览
简要总结
This is a Phase 3 open-label, multicenter, single arm study designed to evaluate the efficacy and safety and tolerability of P1101 patient with PV or ET in long-term.
详细描述
The study is to evaluate the long-term safety and efficacy of P1101 in PV or ET patients who participated in Study A19-201 or Study P1101 ET. The subjects who have completed the 52-week P1101 treatment duration in Study A19-201 will start treatment with P1101 at the dose at Week 50. The subjects who have completed the follow-up/end-of-study visit in Study P1101 ET will start treatment with P1101 at the dose at Week 50. The subjects who were treated with anagrelide will start treatment with P1101 at a dose of 250 μg. The dose of P1101 during this study may be increased or decreased up to 500 μg depending on the condition.
Evaluation of safety will include assessing vital signs, clinical safety laboratory tests, physical examinations, ECG evaluation, heart ECHO, lung X-ray, ECOG performance status, ocular examination, and AEs.
Efficacy evaluations, safety assessments, and immunogenicity evaluations of P1101 will be performed.
Evaluation of efficacy will include clinical laboratory assessments, allelic burden measurements of CALR, JAK-2, and MPL, spleen size measurements, bone marrow sampling.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have completed the 52-week treatment duration in Study A19-201 and are considered by the investigator or sub investigator to be eligible for participation in this study
- •Patients who have given written informed consent to participate in this study
排除标准
- •Patients who are considered by the investigator or sub investigator to be ineligible for continued treatment with P1101
研究组 & 干预措施
P1101 (Ropeginterferon alfa-2b)
Conventional treatment based on phlebotomies, lowdose aspirin (acetylsalicylic acid, 75-150 mg/day) plus the subcutaneous administration of pegylated prolineinterferon alpha-2b (P1101, Ropeginterferon alfa-2b) once every 2 weeks.
干预措施: P1101 (Ropeginterferon alfa-2b) (Biological)
结局指标
主要结局
Maintenance rate of phlebotomy-free complete hematologic response (CHR) every 52 weeks
时间窗: Through study completion, an average of 2 year
CHR will be defined as follows. * Hematocrit \<45% phlebotomy-free (absence of phlebotomy during the previous 12 weeks) * Platelet count ≤ 400 x 10\^9/L * WBC count ≤ 10 x 10\^9/L
次要结局
- Changes in platelet count every 52 weeks over time(Through study completion, an average of 2 year)
- Changes in red blood cell count every 52 weeks over time(Through study completion, an average of 2 year)
- Changes in spleen size every 52 weeks over time(Through study completion, an average of 2 year)
- Changes in hematocrit every 52 weeks over time(Through study completion, an average of 2 year)
- Necessity of phlebotomy(Through study completion, an average of 2 year)
- Changes in white blood cell every 52 weeks over time(Through study completion, an average of 2 year)
- Changes in JAK2 V617F mutant allelic burden value every 52 weeks over time(Through study completion, an average of 2 year)
- Proportion of subjects without thrombotic or hemorrhagic events(Through study completion, an average of 2 year)