RecruitingPhase 1Phase 2NCT05937191

Leflunomide for Idiopathic Pulmonary Hemosiderosis in Children

Leflunomide is Safe and Effective for the Induction and Maintenance of Idiopathic Pulmonary Hemosiderosis Remission


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

34 participants

Start Date

Jun 1, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 5 MonthsMax Age: 18 Years

Inclusion Criteria3

  • 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 Criteria6

  • 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.

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Interventions

DRUGLeflunomide

Leflunomide+Glucocorticoids treatment Group

DRUGSteroid Drug

Steroid Treatment


Locations(1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

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NCT05937191