A Phase III, Randomized, Open-Label, Multicentre Clinical Trial to evaluate the efficacy and safety of Recombinant Human Thrombopoietin (rhTPO) Injection compared with Romiplostim injection in Indian Patients with Immune Thrombocytopenia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 19
- 主要终点
- 1.Compare the complete response rate; Platelet count ≥ 100 X 109 /L and
研究概览
简要总结
This study is A Phase III, Randomized, Open-Label, Multicentre Clinical Trial to evaluate the efficacy and safety of Recombinant Human Thrombopoietin (rhTPO) Injection compared with Romiplostim injection in Indian Patients with Immune Thrombocytopenia.
The Primary endpoints are:
1.Compare the complete response rate; Platelet count ≥ 100 X 109 /L and absence of bleeding between two groups.
2.Compare the response rate ; Platelet count between ≥ 30 X 109 /L and 100 X 109 /L and at least double of the baseline count and absence of bleeding between two groups
3.Compare the total response rate between two groups.
The Secondary endpoints are:
1.Compare the maximum value and increment in platelet count between two groups
2.Compare the frequencies and total volume of platelet transfusion between two groups
3.Observe the time of platelet count to complete response (reaching ≥100×109/L) and maintenance duration.
4.Occurrence of non neutralizing or neutralizing TPO antibodies.
Safety Endpoint
1.The assessment of safety will be based on the frequency of Adverse Event. Change in vital signs and laboratory parameters
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male and Female, aged 18 to 65 years old
- •Meeting the following criteria of ITP: a.
- •Thrombocytopenia by repeated lab tests.
- •Bone marrow examination shows megakaryocyte count increasing or at normal level with dysmaturity.
- •Patients with Platelet count ≤ 20×109/L at any time during the screening period, who are non-responsive to standard or high-dose glucocorticoids.
- •Patients without splenectomy.
- •Patients willing to give written validinformed and signed consent.
排除标准
- •Pregnant or lactating women or patients not willing to adopt contraceptive measures during the trial.
- •Patient with Thrombosis history.
- •Patients with a diagnosis of secondary thrombocytopenia.
- •Patients with hepatorenal dysfunction (serum transaminase and bilirubin are over 1.5 folds of normal upper limit, and creatinine ≥1.5mg/dl).
- •Patients with severe cardiorespiratory dysfunction.
- •Patients who have active malignancy.
- •Patient with hypersensitivity to study drug or any of its excipients.
- •Patients on other thrombopoietin receptor agonists (Eltrombopag) as they compete with TPIAO for TPO receptor binding.
- •Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent.
- •10.Patients with suspected inability to comply with the study procedure.
结局指标
主要结局
1.Compare the complete response rate; Platelet count ≥ 100 X 109 /L and
时间窗: 14 days
absence of bleeding between two groups.
时间窗: 14 days
2. Compare the response rate ;Platelet count between ≥ 30 X 109 /L and 100 X 109 /L and at least double of the baseline count and absence of bleeding between two groups
时间窗: 14 days
3.Compare the total response rate between two groups.
时间窗: 14 days
次要结局
- 1.Compare the maximum value and increment in platelet count between two groups(2.Compare the frequencies and total volume of platelet transfusion between two groups)
- 5.The assessment of safety will be based on the frequency of Adverse Event. Change in vital signs and laboratory parameters(28 days)
- 4.Occurrence of non neutralizing or neutralizing TPO antibodies.(28 days)