NCT05937191

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P50-P75 for phase_1

Timeline
8mo left

Started Jun 2023

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress82%
Jun 2023Dec 2026

Study Start

First participant enrolled

June 1, 2023

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Last Updated

July 10, 2023

Status Verified

June 1, 2023

Enrollment Period

3.6 years

First QC Date

June 30, 2023

Last Update Submit

June 30, 2023

Conditions

Idiopathic Pulmonary HemosiderosisLeflunomide

Keywords

Idiopathic pulmonary hemosiderosisLeflunomideglucocorticoid

Outcome Measures

Primary Outcomes (1)

  • Times of pulmonary hemorrhage

    Annual times of acute episodes of pulmonary hemorrhage

    12 months

Secondary Outcomes (1)

  • Rate of adverse reaction

    12 months

Study Arms (2)

IPH Patients

EXPERIMENTAL

Leflunomide+Steroid treatment

Drug: Leflunomide

Control Group

ACTIVE COMPARATOR

Steroid treatment

Drug: Steroid Drug

Interventions

LeflunomideDRUG

Leflunomide+Glucocorticoids treatment Group

IPH Patients
Steroid DrugDRUG

Steroid Treatment

Control Group

Eligibility Criteria

Age5 Months - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sun Yat-sen Memorial Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510120, China

RECRUITING

MeSH Terms

Conditions

Hemosiderosis, Pulmonary

Interventions

Leflunomide

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesHemosiderosisIron OverloadIron Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

IsoxazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Haiyan Wang, MD

CONTACT

8613560489257wanghy78@mail.sysu.edu.cn

Weiping Tan, PhD

CONTACT

8613556196566tanweip@mail.sysu.edu.cn

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Leflunomide+Stroid treatment Group
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 30, 2023

First Posted

July 10, 2023

Study Start

June 1, 2023

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

December 31, 2026

Last Updated

July 10, 2023

Record last verified: 2023-06

Locations

CN(1)