Leflunomide for Idiopathic Pulmonary Hemosiderosis in Children

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-01

Study Completion Date

2026-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

An Efficacy and Safety Study of Sonazoid™ and SonoVue® in Participants With Focal Liver Lesions, Undergoing Pre- and Post-Contrast Ultrasound Imaging

NCT03335566

Liver Lesions

COMPLETED PHASE3

Nonalcoholic Steatohepatitis in Chinese Children

NCT03190538

Non-Alcoholic Fatty Liver Disease

RECRUITING

The Leukotriene Receptor Antagonist Montelukast in the Treatment of Non-alcoholic Steatohepatitis

NCT04080947

Steatohepatitis, Nonalcoholic

COMPLETED PHASE1/PHASE2

Chinese Phase II Trail of AS1501 in Acute-on-chronic Liver Failure (ACLF) Patients

NCT06916585

Acute-On-Chronic Liver Failure

NOT_YET_RECRUITING PHASE2

Losartan for the Treatment of Pediatric NAFLD

NCT03467217

NAFLD - Nonalcoholic Fatty Liver Disease

TERMINATED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Idiopathic Pulmonary Hemosiderosis Leflunomide

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Leflunomide+Stroid treatment Group

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

IPH Patients

Leflunomide+Steroid treatment

Group Type EXPERIMENTAL

Leflunomide

Intervention Type DRUG

Leflunomide+Glucocorticoids treatment Group

Control Group

Steroid treatment

Group Type ACTIVE_COMPARATOR

Steroid Drug

Intervention Type DRUG

Steroid Treatment

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Leflunomide

Leflunomide+Glucocorticoids treatment Group

Intervention Type DRUG

Steroid Drug

Steroid Treatment

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

5 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No