JPRN-jRCT2031230178已完成2 期
Two Arm Bridging Study to Evaluate the Efficacy of Romiplostim in the Treatment of Adult Severe Aplastic Anemia Participants Who Are Either Previously Untreated With IST or Refractory to IST
Murakami Contact Naoko0 个研究点目标入组 0 人开始时间: 2023年6月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1. Age >= 18 years at time of enrollment
- •2. Diagnosis of SAA/vSAA confirmed by blood, bone marrow, and cytogenetic studies
- •3. An Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1 at screening
- •4. Arm 1 only: participant requires initial treatment for SAA/vSAA, no matched related donor is available for allogenic hematopoietic cell transplantation (HCT) and will begin IST with antithymocyte globulin and CsA
- •5. Arm 2 only: refractory to at least one course of immunosuppressive therapy including horse or rabbit ATG; or ineligible for ATG treatment and refractory to CsA
排除标准
- •1. Diagnosed as having congenital aplastic anemia (AA) (Fanconi anemia, congenital dyskeratosis, etc)
- •2. History of other malignancy within the past 5 years, with exceptions.
- •3. Aplastic anemia with hemolytic paroxysmal nocturnal hemoglobinuria (PNH) (hemolytic predominant is defined as lactate dehydrogenase (LDH) > 1.5 x the upper limit of site normal
- •4. Arm 1 only: Previously treated with ATG, CsA, or Alemtuzumab
- •5. Previously treated with PEGylated recombinant human megakaryocyte growth and development factor (PEG-rHuMGDF), recombinant human thrombopoietin protein (TPO), romiplostim and other TPO-receptor
- •agonist (eltrombopag, etc)
- •6. Patients who are eligible for allogenic HCT and have an available matched related donor
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