NCT02857530Unknown2 期
Efficacy and Safety of Thrombopoietin In Patients With Severe and Very Severe Aplastic Anemia
适应症
干预措施
试验速览
- 阶段
- 2 期
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Time to platelet transfusion independence in patients at 6 month
研究概览
简要总结
Efficacy and Safety of Recombinant human thrombopoietin in patients with severe aplastic anemia and very severe aplastic anemia, a randomized, double-blind, placebo-controlled, II phase, multi-center clinical research.
详细描述
rhTPO
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent
- •Have severe or very severe aplastic anemia
排除标准
- •Have diagnosis of Fanconi anemia
- •Have infection not adequately responding to appropriate therapy
- •Have Paroxysmal Nocturnal Hemoglobinuria (PNH) clone size in neutrophils of greater than or equal to 50%
- •Have creatinine and/or blood urea nitrogen (BUN) ≥2 times the upper limit of normal
- •Have serum bilirubin ≥ 1.5 times the upper limit of normal, or ≥4.0 times the upper limit of normal if the patient has been treated with Anti-Thymocytes globulin（ATG） within three weeks of screening.
- •Have glutamic-oxaloacetic transaminase （AST） and/or glutamic-pyruvic transaminase （ALT） ≥ 3 times the upper limit of normal
- •Are female and are nursing or pregnant or are unwilling to take oral contraceptives or refrain from pregnancy if of childbearing potential
- •Have an Eastern Cooperative Oncology Group (ECOG) performance status of 3 or greater
- •Have had other Thrombopoietin (TPO-R) agonists medication in the previous 4 weeks.
研究组 & 干预措施
rhTPO
Experimental
rhTPO injection
干预措施: rhTPO (Drug)
control
Placebo Comparator
without rhTPO injection
干预措施: placebo (Drug)
结局指标
主要结局
Time to platelet transfusion independence in patients at 6 month
时间窗: 6 month
次要结局
- Overall response rate up to 1 year after Immunosupressive therapy.(up to 1 year)
- Megakaryocyte, granulocyte and erythrocyte recovery in bone marrow up to 1 year after IST.(up to 1 year)
- Time to patients achieve a platelet count 30×10^9/L, 50×10^9/L or100×10^9/L(up to 1year)
- Time to red blood cell/platelet transfusion independence in patients up to 1 year after IST(up to 1 year)
- Hospitalization days of patients.(up to 1 year)
- Number of participants with treatment-related adverse events as assessed by CTCAE v4.0(up to 1 year)
- Percentage of patients achieve red blood cell/platelet transfusion independence at 3, 6, 9 and 12 months after IST.(up to 1 year)
- The reticulocyte count of patients up to 1 year after IST.(up to 1 year)
- Intervals of red blood cell/platelet transfusion up to 1 year after IST.(up to 1 year)
- Median hematopoietic response rate up to 1 year after IST.(up to 1 year)
研究者
ZhongHong Shao
head of department of Hematology
Tianjin Medical University General Hospital
研究点 (1)
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