Leflunomide for Idiopathic Pulmonary Hemosiderosis in Chi... | NCT05937191

Studies
Leflunomide for Idiopathic Pulmonary Hemosiderosis in Children

NCT05937191

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Status

Recruiting

Last Update Posted

Jul 10, 2023Actual

Enrollment

34Estimated

Phase

Phase 1Phase 2

Conditions

Idiopathic Pulmonary Hemosiderosis
Leflunomide

Interventions

Leflunomide
Steroid Drug

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2023

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 1, 2023Actual

Primary Completion Date

Dec 31, 2026Estimated

Completion Date

Dec 31, 2026Estimated

First Submitted Date

Jun 30, 2023

First Submission Date that Met QC Criteria

Jun 30, 2023

First Posted Date

Jul 10, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 30, 2023

Last Update Posted Date

Jul 10, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Weiping Tan, Professor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityPrincipal Investigator

Lead Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

34Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
IPH Patients	Experimental	Leflunomide+Steroid treatment	Drug: Leflunomide
Control Group	Active Comparator	Steroid treatment	Drug: Steroid Drug

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Leflunomide	Drug	Leflunomide+Glucocorticoids treatment Group	IPH Patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Times of pulmonary hemorrhage	Annual times of acute episodes of pulmonary hemorrhage	12 months

Secondary Outcomes

Measure	Description	Time Frame
Rate of adverse reaction	The frequency of adverse reactions and their relationship with leflunomide	12 months

Other Outcomes

Not provided

Eligibility Module

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

5 Months

Maximum Age

18 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Haiyan Wang, MD	Contact	8613560489257		wanghy78@mail.sysu.edu.cn
Weiping Tan, PhD	Contact	8613556196566		tanweip@mail.sysu.edu.cn

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sun Yat-sen Memorial Hospital of Sun Yat-sen University	Recruiting	Guangzhou	Guangdong	510120	China

Condition Browse Module

MeSH Terms

ID	Term
D000097545	Hemosiderosis, Pulmonary

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D006486	Hemosiderosis
D019190	Iron Overload

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000077339	Leflunomide

Ancestor Terms

ID	Term
D007555	Isoxazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided