NCT01255332Unknown不适用
Efficacy of Helicobacter Pylori Eradication for the 1st Line Treatment of Immune Thrombocytopenic Purpura (ITP) Patients With Moderate Thrombocytopenia
Cooperative Study Group A for Hematology1 个研究点 分布在 1 个国家目标入组 26 人开始时间: 2010年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Overall response
研究概览
简要总结
We designed a study for evaluate the efficacy of Helicobacter pylori eradication for the 1st line treatment of immune thrombocytopenic purpura (ITP) patients with moderate thrombocytopenia.
If this eradication treatment is revealed effective on ITP patients with more than 30X109/L of platelet, it would be valuable treatment especially for young ITP patients with mild to moderate thrombocytopenia.
详细描述
lansoprazole 30mg bid, amoxicillin 1000mg bid and clarithromycin 500mg bid for 7 days. (Jeil Pharm. CO. LTD. will provide lansoprazole.) C13-UBT, at 4 weeks after onset of treatment, to determine eradication
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •20~55 years old
- •Persistent or chronic ITP patients, defined by international working group ( persistent: between 3 to 12 months from diagnosis, chronic: lasting for more than 12 months)
- •30X109/L ≤ platelet count ≤ 70X109/L
- •C13-urea breath test: positive
- •no previous ITP treatment
- •no previous H. pylori eradication treatment
- •Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital
排除标准
- •Patients who have any cause of thrombocytopenia such as HIV, HCV infection, lymphoproliferative disease, liver disease, definite SLE, drug, MDS, leukemia
- •Uncontrolled hypothyroidism or hyperthyroidism
- •Acute active bleeding or infection
- •Who taking anti-coagulant or aspirin
- •Patients with penicillin allergy
- •Patients with side effects of macrolide.
- •Patients who taking Mizolastine, Terfenadine, Cisapride, Pimozide, Astemizole, Ergot alkaloid and its derivatives (Ergotamine, Dihydroergotamine), Bepridil, or Atazanavir
- •Patients who have known allergy or severe side effect on study drugs
- •Pregnant or lactating women
- •Clinically relevant hepatic or renal disease (Creatinine clearance ≤ 30mL/min)
- •patients who cannot understand informed consent or express his/her condition
结局指标
主要结局
Overall response
时间窗: 2 years
Overall response rate at 3 months after treatment
次要结局
- Eradication rate of H. pylori(2 years)
研究者
研究点 (1)
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