Using Leflunomide to treat children with Idiopathic Pulmonary Hemosiderosis
Leflunomide is Safe and Effective for the Induction and Maintenance of Idiopathic Pulmonary Hemosiderosis Remission
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 |
| Enrollment | 34 (estimated) |
| Ages | 5 Months to 18 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05937191 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 6 months to 18 years diagnosed with Idiopathic Pulmonary Hemosiderosis.
Not a fit: Patients with serious underlying health conditions or other lung diseases may not benefit from this study.
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 performed: While this approach is novel in the context of IPH, similar studies have shown promise in using Leflunomide for other autoimmune conditions.
Eligibility criteria
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 this trial is running
Guangzhou, Guangdong
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.