Leflunomide for Idiopathic Pulmonary Hemosiderosis in Children (Lef for IPH)

Sun Yat-sen University

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Idiopathic Pulmonary Hemosiderosis; Leflunomide

Treatments: Drug: Leflunomide; Drug: Steroid Drug

Study type: Interventional

Funder types: Other

Identifiers

NCT05937191

2021-KY-001

Details and patient eligibility

About

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.

Full 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.

Enrollment: 34 estimated patients

Sex: All

Ages: 5 months to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

IPH Patients

Experimental group

Description:

Leflunomide+Steroid treatment

Treatment:

Drug: Leflunomide

Control Group

Active Comparator group

Description:

Steroid treatment

Treatment:

Drug: Steroid Drug