High-dose Dexamethasone Plus Diammonium Glycyrrhizinate Enteric-coated Capsule Versus High-dose Dexamethasone in Treatment-naive Primary Immune Thrombocytopenia (ITP): a Multicentre, Randomised, Open-label Trial
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 106
- 试验地点
- 2
- 主要终点
- 14-day initial overall response to ITP treatments
研究概览
简要总结
The project was undertaking by Qilu Hospital of Shandong University in China. In order to report the efficacy and safety of diammonium glycyrrhizinate enteric-coated capsule plus high-dose dexamethasone for the treatment of adults with newly-diagnosed primary immune thrombocytopenia (ITP).
详细描述
The investigators anticipate to undertaking a parallel group, randomised controlled trial of 106 ITP patients. One part of the participants are randomly selected to receive diammonium glycyrrhizinate enteric-coated capsule orally at a dose of 150mg tid for 1 month), combining with dexamethasone (given orally at a dose of 40 mg qd for 4 days). The others are selected to receive high-dose of dexamethasone alone. Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study. The purpose of this study is to report the efficacy and safety of diammonium glycyrrhizinate enteric-coated capsule combining with high-dose dexamethasone therapy for the treatment of ITP.
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
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for immune thrombocytopenia;
- •Untreated hospitalized patients or patients from the clinic, may be male or female, between the ages of 18~ 80 years;
- •To show a platelet count <30 * 10^9/L, or with bleeding manifestations, or both;
- •Willing and able to sign written informed consent
- •ITP patients with hepatitis virus infection or ITP patients with abnormal liver function at the time of enrollment, i.e., ITP patients with indications for diammonium glycyrrhizinate enteric-coated capsule, should be separately stratified.
排除标准
- •secondary thrombocytopenia;
- •severe immune-deficiency;
- •active or previous malignancy;
- •HIV virus infection, tuberculosis, or other active infection (sepsis, pneumonia, or abscess);
- •pregnancy or lactation;
- •diabetes;
- •hypertension;
- •cardiovascular diseases;
- •severe kidney function impairment;
- •psychosis;
- •osteoporosis;
- •inflammatory bowel disease or gastric disease;
- •arterial or venous thromboembolism within the 6 months before screening or patients who required anticoagulant treatment;
- •an organ or haematopoietic stem-cell transplantation;
- •neutrophil count of less than 1500 cells per mm³;
- •glycosylated haemoglobin less than 8%;
- •partial thromboplastin time 1∙5 times or less the upper limit of normal (ULN); •clinical electrocardiogram changes;
- •history of primary immunodeficiency;
- •neoplastic disease within the past 5 years;
- •corrected QT interval greater than 450 ms for men and greater than 470 ms for women;
- •substance misuse within the previous 12 months;
- •people who could not adhere to the protocol or were planning to have a surgical procedure in 6 months.
研究组 & 干预措施
diammonium glycyrrhizinate enteric-coated capsule + high-dose dexamethasone
Diammonium glycyrrhizinate enteric-coated capsule orally at a dose of 150mg tid for 1 month, combining with dexamethasone (given orally at a dose of 40 mg qd for 4 days). Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days.
干预措施: dexamethasone (Drug)
diammonium glycyrrhizinate enteric-coated capsule + high-dose dexamethasone
Diammonium glycyrrhizinate enteric-coated capsule orally at a dose of 150mg tid for 1 month, combining with dexamethasone (given orally at a dose of 40 mg qd for 4 days). Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days.
干预措施: diammonium glycyrrhizinate enteric-coated capsule (Drug)
High-dose dexamethasone
Dexamethasone orally at a dose of 40 mg qd for 4 days. Patients who do not respond to the treatment may receive another cycle of high-dose dexamethasone therapy with an interval of 10 days.
干预措施: dexamethasone (Drug)
结局指标
主要结局
14-day initial overall response to ITP treatments
时间窗: 14 days after treatment started
Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.
6-month sustained overall response to ITP treatments
时间窗: A response lasting for at least 6 months without any additional intervention specific to primary immune thrombocytopenia was defined as a sustained response
Complete response was defined as a platelet count of 100×10⁹ cells per L or higher and an absence of bleeding. Partial response was defined as a platelet count of 30×10⁹ cells per L or higher, but less than 100×10⁹ cells per L, and at least a doubling of the baseline platelet count and an absence of bleeding. Platelet counts were confirmed on two separate occasions at least 7 days apart when defining complete response or partial response. No response was defined as a platelet count of less than 30×10⁹ cells per L, or less than two-times increase from baseline platelet count, or bleeding.
次要结局
- therapy associated adverse events(up to one year)
- time to response(an average of 6 months)
- duration of response(through study completion, an average of one year)
研究者
Ming Hou
Professor and Director
Shandong University