Leflunomide for Idiopathic Pulmonary Hemosiderosis in Children
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Leflunomide, Steroid Drug.
- Who it may be relevant to
- Registry conditions: Idiopathic Pulmonary Hemosiderosis, Leflunomide. Basic parameters: 5 months — 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Leflunomide is Safe and Effective for the Induction and Maintenance of Idiopathic Pulmonary Hemosiderosis Remission
Overview
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
- Drug Leflunomide
Leflunomide+Glucocorticoids treatment Group - Drug Steroid Drug
Steroid Treatment
Primary outcome measures
- Times of pulmonary hemorrhage [Time frame: 12 months]
Secondary outcome measures (1)
- Rate of adverse reaction [Time frame: 12 months]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Sun Yat-sen Memorial Hospital of Sun Yat-sen University — Guangzhou
Identifiers
NCT: NCT05937191 · 2021-KY-001