Idiopathic Pulmonary Hemosiderosis, Leflunomide
Conditions
Keywords
Idiopathic pulmonary hemosiderosis, Leflunomide, glucocorticoid
Brief summary
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.
Detailed description
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.
Interventions
DRUGLeflunomide
Leflunomide+Glucocorticoids treatment Group
DRUGSteroid Drug
Steroid Treatment
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Leflunomide+Stroid treatment Group
Eligibility
Sex/Gender
ALL
Age
5 Months to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Age range from 6 months to 18 years old; 2. Diagnose as IPH; 3. Parents or guardians agree to treatment and sign a written informed consent form.
Exclusion criteria
1. Individuals who are allergic to any ingredients used in leflunomide tablets; 2. 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); 3. Patients with other lung diseases; 4. Have a history of abnormal coagulation or abnormal coagulation function in the past; 5. Clinical trial participants who have previously participated in the treatment of flumiphene; 6. Other situations where the researcher deems it inappropriate to participate in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Times of pulmonary hemorrhage | 12 months | Annual times of acute episodes of pulmonary hemorrhage |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of adverse reaction | 12 months | The frequency of adverse reactions and their relationship with leflunomide |
Countries
China
Contacts
Primary ContactHaiyan Wang, MD
Backup ContactWeiping Tan, PhD
Outcome results
None listed