Efficacy of Helicobacter Pylori Eradication for the Treatment of Chronic or Persistent Immune Thrombocytopenic Purpura Patients With Moderate Thrombocytopenia: Multicenter Prospective Randomized Phase 3 Study
试验速览
- 阶段
- 3 期
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- overall response rate (ORR: complete response + response rate) of platelets
研究概览
简要总结
The purpose of this study is to determine the efficacy of H. pylori eradication for the treatment of chronic or persistent immune thrombocytopenic purpura (ITP) patients with moderate thrombocytopenia. This is a multi-center, open label, prospective randomized phase IIl study.
详细描述
Current treatment guideline of ITP recommends corticosteroid as the first line treatment when patient has active bleeding or less than 30×10^9/L of platelet, because of side effect and cost issues. Since the first case report by Italian study, several investigators have reported that secondary immune thrombocytopenia (ITP) can occur in patients with Helicobacter pylori (H. pylori) infection. We already reported the efficacy of H. pylori eradication in moderate ITP patients with phase II study (Annals Hematology 2015:94:739-46). To improve the evidence of this strategy for the treatment of moderate ITP, we plan to start this multi-center, open label, prospective randomized phase 3 study.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 19 years
- •Persistent or chronic ITP patients defined by international working group
- •30 X 10^9/L ≤ platelet level ≤ 80 X 10^9/L
- •H. pylori infection should be confirmed by at least one of tests: urea breath test (UBT), CLO, stool H. pylori Ag, H. pylori in gastric tissue (reported by a trained pathologist)
- •No history of any ITP treatment for the past 3 months
- •No previous history of H. pylori eradication treatment
- •Patients who voluntarily participate in this study and with informed consents
排除标准
- •patients who have any cause of thrombocytopenia such as HIV, HCV infection, lymphoproliferative disease, malignant neoplasm, liver disease, definite SLE and other autoimmune diseases, drugs, MDS and leukemia
- •uncontrolled hypothyroidism or hyperthyroidism
- •active bleeding for the past 3 months or history of hemorrhagic gastric ulcer or brain hemorrhage
- •active infection
- •patients who are taking anticoagulant or aspirin
- •patients with penicillin allergy or side effects of macrolide
- •patients who are taking mizolastine, terfenadine, cisapride, pimozide, astemizole, ergot alkaloid and its derivatives (ergotamine and dihydroergotamine), bepridil or atazanavir
- •patients who have known allergy or severe side effect on study drugs
- •pregnant or lactating women
研究组 & 干预措施
Treatment arm: H. pylori eradication
treatment arm: H. pylori eradication at visit 1(0 month)
干预措施: treatment : H. pylori eradication (Drug)
Control arm -1st stage
At visit 1(0 month) no intervention, observation only from visit 1 to visit 3
Control arm - 2nd stage
Same patients group with control arm 1st stage. After observation for 3 months during stage 1, the patients of control arm will be treated with same regimen for H. pylori eradication at visit 4 (2nd stage).
干预措施: treatment : H. pylori eradication (Drug)
结局指标
主要结局
overall response rate (ORR: complete response + response rate) of platelets
时间窗: visit 4 (3 months after randomization)
1. ORR between treatment group with UBT (-) and control group with stage 1 2. International working group criteria for ITP treatment response will be used for ORR definition
次要结局
- ORR between treatment group and control group with stage 1(visit 4 (3 months after randomization))
- ORR of control group with stage 2(At visit 5 (6 months after randomization))
- ORR after H. pylori eradication in all patients who were treated and UBT (-)(3 months after H. pylori eradication)
- Time to response(from initiation date of study drugs to the date of R or CR (assessed up to 6 months))
- Response duration(from the date of R or CR to the date of loss of R or CR / or till last f/u date, whichever came first (assessed up to 6 months))
- H. pylori eradication rate(at vist 4 (3 months after randomization) after drug treatment)
- drug toxicity and compliance(At visit 2, 3, 4, 5 (1, 2, 3, 6 months after randomization, respectively) for treatment group, at visit 5 (6 months after randomization) for control group stage 2)
- QoL(At visit 1(Day 1 of study drug medication) & vist 4 (3 months after randomization))
- platelet level at randomization(3 months after H. pylori eradication)
- ITP duration before randomization(3 months after H. pylori eradication)
研究者
Soo-Mee Bang
Professor, Department of Internal Medicine
Seoul National University Hospital