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Leflunomide for Idiopathic Pulmonary Hemosiderosis in Children

Leflunomide for Idiopathic Pulmonary Hemosiderosis in Children

Recruiting
5-18 years
All
Phase 1/2

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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.

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.

Eligibility

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.

Study details
    Idiopathic Pulmonary Hemosiderosis
    Leflunomide

NCT05937191

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

28 January 2024

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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