Leflunomide for Idiopathic Pulmonary Hemosiderosis in Children

Idiopathic Pulmonary Hemosiderosis Clinical Trial

— Lef for IPH  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05937191
• Other study ID #: 2021-KY-001
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: June 1, 2023
• Est. completion date: December 31, 2026

Study information

• Verified date: June 2023
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Haiyan Wang, MD
• Phone: 8613560489257
• Email: wanghy78[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 34
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 5 Months to 18 Years

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.

Related Conditions & MeSH terms

• Hemochromatosis
• Hemosiderosis
• Idiopathic Pulmonary Hemosiderosis
• Lung Diseases

Intervention

Drug:
• Leflunomide
Leflunomide+Glucocorticoids treatment Group
• Steroid Drug
Steroid Treatment

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital of Sun Yat-sen University	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Times of pulmonary hemorrhage	Annual times of acute episodes of pulmonary hemorrhage	12 months
Secondary	Rate of adverse reaction	The frequency of adverse reactions and their relationship with leflunomide	12 months