A Multicenter Randomized Open-label Clinical Trial of Vitamin D Combined With HD-DXM Versus HD-DXM for the Treatment of ITP
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Sustained 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 vitamin D combining with 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 prospective, multicenter, randomised controlled trial of 60 ITP adult patients. One part of the participants are randomly selected to receive vitamin D (given Rocaltrol orally at a dose of 0.25 μg per day for 1 month), combining with dexamethasone (given orally at a dose of 40 mg per day for 4 days, two-cycles with an interval of 10 days); the others are selected to receive high-dose of dexamethasone treatment plus placebo. Platelet count, bleeding and other symptoms were evaluated before and after treatment. Serum calcium and creatinine are monitored. Adverse events are also recorded throughout the study. In order to report the efficacy and safety of vitamin D combining with high-dose dexamethasone therapy for the treatment of adults with 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
- •Corresponding to the diagnostic criteria for immune thrombocytopenia
- •Newly diagnosed ITP patients
- •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
- •Suffered from diseases associated with hypercalcemia.
- •Vitamin D intoxication
- •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; 3.Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study;
- •Current HIV infection;
- •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
Rocaltrol Combining HD-DXM
Rocaltrol 0.25 μg once per day, 1 month; HD-DXM (orally at 40 mg daily for 4d )
干预措施: Rocaltrol (Drug)
Rocaltrol Combining HD-DXM
Rocaltrol 0.25 μg once per day, 1 month; HD-DXM (orally at 40 mg daily for 4d )
干预措施: Dexamethasone (Drug)
HD-DXM
HD-DXM (orally at 40 mg daily for 4d )
干预措施: Rocaltrol (Drug)
结局指标
主要结局
Sustained response to ITP treatments
时间窗: 3 months after treatment started
Percentage of patients maintaining PLT count over 30\*10\^9 without bleeding
次要结局
- Evaluation of platelet response(3 months after treatment started)
研究者
Ming Hou
Professor
Shandong University