Leflunomide is Safe and Effective for the Induction and Maintenance of Idiopathic Pulmonary Hemosiderosis Remission
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Times of pulmonary hemorrhage
研究概览
简要总结
The goal of this clinical trial is to compare Leflunomide in Idiopathic pulmonary hemosiderosis. The main questions it aims to answer are:
- The efficacy and safety of Leflunomide in Idiopathic pulmonary hemosiderosis
- The mechanism of leflunomide in treating Idiopathic pulmonary hemosiderosis Participants will be treated with leflunomide plus stroid. A comparison group: Researchers will compare the control group treated with stroid to see if the efficacy of Leflunomide would be better than control group.
详细描述
This study conducted a prospective, open, parallel controlled, single center clinical trial on the combination of Leflunomide and Stroid therapy for children with IPH, and conducted a one-year follow-up. The main indicators (pulmonary hemorrhage/hemoptysis frequency) and secondary indicators (serum iron metabolism level, T lymphocyte subpopulation, lung function, inflammatory cells, and inflammatory factors) were evaluated before and after treatment, Exploring the safety and effectiveness of leflunomide in the treatment of IPH, it is expected that the combination of leflunomide and conventional treatment can improve the remission rate of clinical symptoms in children with IPH, inhibit the progressive deterioration of lung function, and the research results are expected to bring new treatment methods and strategies for this group of patients.
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
- 5 Months 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age range from 6 months to 18 years old;
- •Diagnose as IPH;
- •Parents or guardians agree to treatment and sign a written informed consent form.
排除标准
- •Individuals who are allergic to any ingredients used in leflunomide tablets;
- •Complicated with serious basic diseases (such as systemic malignant diseases, heart failure, liver and kidney failure, immune deficiency, serious infectious diseases, Lung transplantation or other patients with immediate surgical indications);
- •Patients with other lung diseases;
- •Have a history of abnormal coagulation or abnormal coagulation function in the past;
- •Clinical trial participants who have previously participated in the treatment of flumiphene;
- •Other situations where the researcher deems it inappropriate to participate in the study.
研究组 & 干预措施
IPH Patients
Leflunomide+Steroid treatment
干预措施: Leflunomide (Drug)
Control Group
Steroid treatment
干预措施: Steroid Drug (Drug)
结局指标
主要结局
Times of pulmonary hemorrhage
时间窗: 12 months
Annual times of acute episodes of pulmonary hemorrhage
次要结局
- Rate of adverse reaction(12 months)
研究者
Weiping Tan
Professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University