Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 5 Months to 18

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

PhasePhase1; Phase2
Study typeInterventional
Ages5 Months to 18 Years
SexAll
Enrollment34 (estimated)
SponsorSun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Academic / other
Locations1 site (Guangzhou, Guangdong)
StatusRecruiting
StartedJune 1, 2023
Main results expectedDecember 31, 2026
Study endsDecember 31, 2026
Registry record updatedJuly 10, 2023
Trial IDNCT05937191 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

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University
    Guangzhou, Guangdong, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.