Trials / Recruiting
RecruitingNCT05937191
Leflunomide for Idiopathic Pulmonary Hemosiderosis in Children
Leflunomide is Safe and Effective for the Induction and Maintenance of Idiopathic Pulmonary Hemosiderosis Remission
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 34 (estimated)
- Sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
- Sex
- All
- Age
- 5 Months – 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Leflunomide | Leflunomide+Glucocorticoids treatment Group |
| DRUG | Steroid Drug | Steroid Treatment |
Timeline
- Start date
- 2023-06-01
- Primary completion
- 2026-12-31
- Completion
- 2026-12-31
- First posted
- 2023-07-10
- Last updated
- 2023-07-10
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05937191. Inclusion in this directory is not an endorsement.