Leflunomide for Idiopathic Pulmonary Hemosiderosis in Children

Phase 1

Recruiting

• Conditions: Idiopathic Pulmonary Hemosiderosis; Leflunomide
• Interventions: Drug: Steroid Drug; Drug: Leflunomide

• Registration Number: NCT05937191
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-06-01
• Study First Submitted: 2023-06-30
• Study First Submitted QC: 2023-06-30
• Last Update Submitted: 2023-06-30
• Study First Posted: 2023-07-10
• Last Update Posted: 2023-07-10
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 34

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Steroid Drug	Steroid treatment
IPH Patients	Leflunomide	Leflunomide+Steroid treatment

Primary Outcome Measures

Name	Time	Method
Times of pulmonary hemorrhage	12 months	Annual times of acute episodes of pulmonary hemorrhage

Secondary Outcome Measures

Name	Time	Method
Rate of adverse reaction	12 months	The frequency of adverse reactions and their relationship with leflunomide

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China