Using Leflunomide to treat children with Idiopathic Pulmonary Hemosiderosis
Official title: Leflunomide is Safe and Effective for the Induction and Maintenance of Idiopathic Pulmonary Hemosiderosis Remission
Run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · NCT05937191 · Data updated 2026-11-12
This study is testing if adding Leflunomide to steroid treatment can help children with Idiopathic Pulmonary Hemosiderosis feel better and protect their lung function.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 5 Months to 18 Years |
| Sex | All |
| Enrollment | 34 (estimated) |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Status | Recruiting |
| Started | June 1, 2023 |
| Main results expected | December 31, 2026 |
| Study ends | December 31, 2026 |
| Registry record updated | July 10, 2023 |
| Trial ID | NCT05937191 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are children aged 6 months to 18 years diagnosed with Idiopathic Pulmonary Hemosiderosis.
✕Probably not a fit
Patients with serious underlying health conditions or other lung diseases may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of Leflunomide in treating children diagnosed with Idiopathic Pulmonary Hemosiderosis (IPH). Participants aged 6 months to 18 years will receive Leflunomide in combination with steroid therapy, while a control group will receive only steroids. The study will assess various indicators, including the frequency of pulmonary hemorrhage and lung function, over a one-year follow-up period. The goal is to determine if Leflunomide can improve clinical symptoms and inhibit lung function deterioration in these patients.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for children suffering from Idiopathic Pulmonary Hemosiderosis.
How similar studies have gone: While this approach is novel in the context of IPH, similar studies have shown promise in using Leflunomide for other autoimmune conditions.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting
Study contacts
- Study coordinator: Haiyan Wang, MD
- Email: wanghy78@mail.sysu.edu.cn
- Phone: 8613560489257
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.