Study on Glucocorticoid Combined With Gamma Globulin and Ropristine N01 in Treatment of Initial Severe ITP
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- The total effective rate of treatment for 30 days
研究概览
简要总结
The goal of this clinical trial is to learn if romiplostim N01 works to treat severe primary immune thrombocytopenia in adults. It will also learn about the safety of romiplostim N01. The main question it aims to answer is:
TO evaluate the effectiveness of the combination treatment of glucocorticoids, gamma globulin and romiplostim N01 in patients with severe primary immune thrombocytopenia during the initial treatment period for one month.
Participants will:
Romiplostim N01, starting dose of 1 µg/kg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month.
IVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days.
Prednisone, 0.8mg/kg/d, taken orally or intravenously, for up to one month.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must sign a written informed consent prior to enrollment;
- •Ages 18-75;
- •Platelet count <10×10^9/L with active bleeding or bleeding score ≥5;
- •No contraindications to the use of steroids, romiplostim, or IVIG, and willingness to receive these treatments;
- •No prior splenectomy or at least one first-line ITP treatment or emergency treatment;
- •No prior romiplostim treatment;
- •ECOG PS score: 0-2;
- •Female participants of childbearing potential must agree to use reliable contraception (including male or female condoms, contraceptive foam, contraceptive jelly, contraceptive patches, contraceptive cream, contraceptive suppositories, abstinence, and placement of intrauterine contraceptive devices) throughout the study; women who have had a hysterectomy, bilateral oophorectomy, bilateral salpingo-oophorectomy, or have been postmenopausal for more than 1 year, and men who have had bilateral vasectomy or vasectomy are excluded;
- •Voluntary participation in this study and good compliance.
排除标准
- •Individuals with the following hematological disorders other than ITP, including but not limited to leukemia, thrombocytopenia caused by cancer treatment, myeloproliferative diseases, multiple myeloma, and myelodysplastic syndrome;
- •Individuals with a history of thrombosis;
- •Pregnant or lactating individuals;
- •Individuals with severe cardiopulmonary insufficiency;
- •Individuals with severe or uncontrollable infections;
- •Individuals with viral infections;
- •Individuals who cannot comply due to psychological reasons;
- •Individuals who are deemed unsuitable for participation in the study by the investigator.
研究组 & 干预措施
Corticosteroids combined with immunoglobulin and romiplostim
Romiplostim N01, starting dose of 1 µg/kg, subcutaneous injection, given on the third day of IVIG, once a week, for up to one month.
IVIG, 400mg/kg/d, intravenous administration, continuous administration for 3-5 days.
Prednisone, 0.8mg/kg/d, taken orally or intravenously, for up to one month.
干预措施: corticosteroids combined with immunoglobulin and romiplostim (Drug)
结局指标
主要结局
The total effective rate of treatment for 30 days
时间窗: one months
GR = CR + R (Complete reaction CR, platelet count ≥ 100×10\^9/L, and no bleeding symptoms; Effective R, platelet count between 30×10\^9/L and 100×10\^9/L, and at least double the baseline value, and no bleeding symptoms)
次要结局
- Early (week) response rate R(one months)
- Early Complete Response Rate (CR)(one months)
- Time to Reaction(one months)
- Adverse events during treatment(four months)