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

Primary Purpose

Idiopathic Pulmonary Hemosiderosis, Leflunomide

Status
Recruiting
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Leflunomide
Steroid Drug
Sponsored by
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Hemosiderosis focused on measuring Idiopathic pulmonary hemosiderosis, Leflunomide, glucocorticoid

Eligibility Criteria

5 Months - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age range from 6 months to 18 years old; Diagnose as IPH; Parents or guardians agree to treatment and sign a written informed consent form. Exclusion Criteria: Individuals who are allergic to any ingredients used in leflunomide tablets; 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); Patients with other lung diseases; Have a history of abnormal coagulation or abnormal coagulation function in the past; Clinical trial participants who have previously participated in the treatment of flumiphene; Other situations where the researcher deems it inappropriate to participate in the study.

Sites / Locations

  • Sun Yat-sen Memorial Hospital of Sun Yat-sen UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IPH Patients

Control Group

Arm Description

Leflunomide+Steroid treatment

Steroid treatment

Outcomes

Primary Outcome Measures

Times of pulmonary hemorrhage
Annual times of acute episodes of pulmonary hemorrhage

Secondary Outcome Measures

Rate of adverse reaction
The frequency of adverse reactions and their relationship with leflunomide

Full Information

First Posted
June 30, 2023
Last Updated
June 30, 2023
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05937191
Brief Title
Leflunomide for Idiopathic Pulmonary Hemosiderosis in Children
Acronym
Lef for IPH
Official Title
Leflunomide is Safe and Effective for the Induction and Maintenance of Idiopathic Pulmonary Hemosiderosis Remission
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
December 31, 2026 (Anticipated)
Study Completion Date
December 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Hemosiderosis, Leflunomide
Keywords
Idiopathic pulmonary hemosiderosis, Leflunomide, glucocorticoid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Leflunomide+Stroid treatment Group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
34 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
IPH Patients
Arm Type
Experimental
Arm Description
Leflunomide+Steroid treatment
Arm Title
Control Group
Arm Type
Active Comparator
Arm Description
Steroid treatment
Intervention Type
Drug
Intervention Name(s)
Leflunomide
Intervention Description
Leflunomide+Glucocorticoids treatment Group
Intervention Type
Drug
Intervention Name(s)
Steroid Drug
Intervention Description
Steroid Treatment
Primary Outcome Measure Information:
Title
Times of pulmonary hemorrhage
Description
Annual times of acute episodes of pulmonary hemorrhage
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Rate of adverse reaction
Description
The frequency of adverse reactions and their relationship with leflunomide
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Months
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age range from 6 months to 18 years old; Diagnose as IPH; Parents or guardians agree to treatment and sign a written informed consent form. Exclusion Criteria: Individuals who are allergic to any ingredients used in leflunomide tablets; 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); Patients with other lung diseases; Have a history of abnormal coagulation or abnormal coagulation function in the past; Clinical trial participants who have previously participated in the treatment of flumiphene; Other situations where the researcher deems it inappropriate to participate in the study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Haiyan Wang, MD
Phone
8613560489257
Email
wanghy78@mail.sysu.edu.cn
First Name & Middle Initial & Last Name or Official Title & Degree
Weiping Tan, PhD
Phone
8613556196566
Email
tanweip@mail.sysu.edu.cn
Facility Information:
Facility Name
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiping Tan, PhD
Phone
+8613556196566
Email
tanwp@mail.sysu.edu.cn

12. IPD Sharing Statement

Learn more about this trial

Leflunomide for Idiopathic Pulmonary Hemosiderosis in Children

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