A Multicentre Randomized Study of Caffeic Acid Tablets as a Second-line Therapy for the Treatment of Immune Thrombocytopenia (ITP)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Proposed criteria for assessing response to ITP treatments
研究概览
简要总结
The investigators are undertaking a multicentre, randomised controlled trial of 120 adults with newly diagnosed ITP from 5 medical centers in China. Part of the participants are randomly selected to receive caffeic acid tablets combining dexamethasone and the other part are selected to receive high-dose dexamethasone treatment. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Adverse events are also recorded throughout the study.
详细描述
All participants' platelet count will be monitored weekly. Response will be evaluated after 3, 6 and 12 months after treatment. If the participant did not get complete response or response after 3 months, he would quit the trail.
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, may be male or female, between the ages of 18 ~ 80 years
- •To show a platelet count <30 * 10^9/L, and with bleeding manifestations
- •Willing and able to sign written informed consent
排除标准
- •Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit
- •Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit
- •Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study
- •Current HIV infection or hepatitis B virus or hepatitis C virus infections
- •Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
- •Female patients who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period
- •Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test
- •Patients who are deemed unsuitable for the study by the investigator
研究组 & 干预措施
caffeic acid tablet and dexamethasone
Oral administration of caffeic acid tablet 0.3g three times per day for 1 year. Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total.
干预措施: Caffeic acid (Drug)
caffeic acid tablet and dexamethasone
Oral administration of caffeic acid tablet 0.3g three times per day for 1 year. Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total.
干预措施: Dexamethasone (Drug)
Placebo and dexamethasone
Oral administration of placebo tablet 0.3g three times per day for 1 year. Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total.
干预措施: Dexamethasone (Drug)
Placebo and dexamethasone
Oral administration of placebo tablet 0.3g three times per day for 1 year. Oral administration of dexamethasone 40 mg for four consecutive days then proceed another cycle 10 days later, 3 cycles in total.
干预措施: Placebo (Drug)
结局指标
主要结局
Proposed criteria for assessing response to ITP treatments
时间窗: 3 months after treatment started
1. Complete response (CR)： A platelet count ≥ 100 \* 10\^9/L measured on two occasions \> 7 days apart and the absence of bleeding. 2. Response (R)： A platelet count ≥ 30 \* 10\^9/L and a greater than two fold increase in platelet count from baseline measured on two occasions \> 7 days apart and the absence of bleeding. 3. No response (NR)： A platelet count \< 30 \* 10\^9/L or a less than two fold increase in platelet count from baseline or the presence of bleeding. Platelet count must be measured on two occasions more than a day apart. 4. Relapses: platelet count falls below 30×10\^9/L or bleeding accrues after achieving R or CR.
次要结局
未报告次要终点
研究者
Ming Hou
Professor and Director
Shandong University