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RecruitingNCT05937191Lef for IPHUpdated Jul 10, 2023

Leflunomide for Idiopathic Pulmonary Hemosiderosis in Children

A Phase 1/2 interventional study of Leflunomide and Steroid Drug in Idiopathic Pulmonary Hemosiderosis and Leflunomide, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruiting at 1 site in China. Open to participants aged 5 Months to 18 Years. Per ClinicalTrials.gov, last updated 2023-07-10.

Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
34
Allocation
Randomized
Ages
5 Months to 18 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Idiopathic Pulmonary Hemosiderosis
  • Leflunomide

Keywords

  • Idiopathic pulmonary hemosiderosis
  • Leflunomide
  • glucocorticoid
03

Who can participate

Ages eligible
5 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
34 participants (estimated)

Study arms

  • Experimental
    IPH Patients

    Leflunomide+Steroid treatment

    Drug: Leflunomide

  • Active comparator
    Control Group

    Steroid treatment

    Drug: Steroid Drug

Interventions

  • DrugLeflunomide

    Leflunomide+Glucocorticoids treatment Group

  • DrugSteroid Drug

    Steroid Treatment

05

What researchers measure

Primary outcomes

  1. Times of pulmonary hemorrhage

    Annual times of acute episodes of pulmonary hemorrhage

    Time frame: 12 months

Secondary outcomes

  1. Rate of adverse reaction

    The frequency of adverse reactions and their relationship with leflunomide

    Time frame: 12 months

06

Study locations

1 of 1 sites recruiting
  • Sun Yat-sen Memorial Hospital of Sun Yat-sen University
    Guangzhou, Guangdong 510120, China
    Recruiting
07

Registry details

Key details

Study ID
NCT05937191
Lead sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Responsible party
Weiping Tan (Professor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University) — Principal investigator
First posted
Jul 10, 2023
Start date
Jun 1, 2023
Primary completion
Dec 31, 2026 (estimated)
Completion
Dec 31, 2026 (estimated)
Last update
Jul 10, 2023

Study contacts

Haiyan Wang, MD
Contact
wanghy78@mail.sysu.edu.cn
8613560489257
Weiping Tan, PhD
Contact
tanweip@mail.sysu.edu.cn
8613556196566

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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