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NCT Number: NCT05937191

Leflunomide for Idiopathic Pulmonary Hemosiderosis in Children

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.

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Key information

Age range

5 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

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

Guangzhou, Guangdong, 510120, China

Location status: Recruiting

Location contact

Weiping Tan, PhD

CONTACT

[email protected]

+8613556196566

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

leflunomide

Drug

Leflunomide+Glucocorticoids treatment Group

Steroid Drug

Drug

Steroid Treatment

Primary outcomes

  1. Times of pulmonary hemorrhage

    Time frame: 12 months

    Annual times of acute episodes of pulmonary hemorrhage

Secondary outcomes

  1. Rate of adverse reaction

    Time frame: 12 months

    The frequency of adverse reactions and their relationship with leflunomide

Study contacts

Contact information is provided by the study sponsor or research team.

Haiyan Wang, MD

CONTACT

[email protected]

8613560489257

Weiping Tan, PhD

CONTACT

[email protected]

8613556196566

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Acronym: Lef for IPH

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2023
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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