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Leflunomide for Henoch-Schonlein Purpura (Lef for HSP)

Primary Purpose

Henoch-Schonlein Purpura

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Leflunomide
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 Henoch-Schonlein Purpura focused on measuring Leflunomide, Henoch-Schonlein Purpura, Children, Efficacy

Eligibility Criteria

1 Year - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age ranges from 1 to 18 years old; Patients meet the HSP diagnostic criteria; Refractory skin type HSP: Rashes are dense and large in area, often treated with antibiotics, antihistamines, calcium supplements, and glucocorticoids (2 mg/kg/d) for 5 days. The rash does not subside or fresh rash still appears, and frequently repeated more than 3 times during hospitalization. Parents or guardians agree to treatment and sign a written informed consent form. Exclusion Criteria: Individuals who are allergic to leflunomide; Concomitant severe underlying diseases (such as systemic malignancy, heart failure, liver and kidney failure, immune deficiency, severe infectious diseases, organ transplant surgery, or other current indications for emergency surgery); Patients with other digestive system diseases; Those who have previously used flumiphene in clinical trials; Excluding purpura caused by drugs, infectious factors, and other autoimmune diseases. Other situations where the researcher deems it inappropriate to participate in the study.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Administration of Leflunomide in refractory skin Henoch-Schonlein purpura

Arm Description

Rashes are dense and large in area, often treated with antibiotics, antihistamines, calcium supplements, and glucocorticoids (2 mg/kg/d) for 5 days. The rash does not subside or new rash still appears, and it frequently repeats more than 3 times during hospitalization.

Outcomes

Primary Outcome Measures

Rash frequency
Rash frequency in a months

Secondary Outcome Measures

Full Information

First Posted
June 25, 2023
Last Updated
July 1, 2023
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
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1. Study Identification

Unique Protocol Identification Number
NCT05937880
Brief Title
Leflunomide for Henoch-Schonlein Purpura
Acronym
Lef for HSP
Official Title
Leflunomide for Refractory Skin Henoch-Schonlein Purpura in Children
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (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
This study conducted a prospective, multicenter, one-arm clinical trial on the combination of leflunomide and steroid therapy for refractory skin Henoch-Schonlein Purpura in children on the basis of ethical principles. A one-year follow-up was conducted to evaluate the changes in the main indicators (frequency of rash recurrence) and secondary indicators (proportion of kidney damage, proportion of joint involvement, T lymphocyte subpopulations, and inflammatory factors) before and after treatment, Exploring the safety and effectiveness of leflunomide in the treatment of refractory skin type HSP in children, it is expected that leflunomide combined with conventional treatment can improve the remission rate of HSP children's skin purpura and reduce HSP recurrence. 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
Henoch-Schonlein Purpura
Keywords
Leflunomide, Henoch-Schonlein Purpura, Children, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Refractory skin Henoch-Schonlein Purpura
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Administration of Leflunomide in refractory skin Henoch-Schonlein purpura
Arm Type
Experimental
Arm Description
Rashes are dense and large in area, often treated with antibiotics, antihistamines, calcium supplements, and glucocorticoids (2 mg/kg/d) for 5 days. The rash does not subside or new rash still appears, and it frequently repeats more than 3 times during hospitalization.
Intervention Type
Drug
Intervention Name(s)
Leflunomide
Intervention Description
When patients appeared with rashes and treated with antibiotics, antihistamines, calcium supplements, and glucocorticoids (2 mg/kg/d) for 5 days. The rashes do not subside or fresh rash still appears, and it frequently repeats more than 3 times during hospitalization. Leflunomide would be administered
Primary Outcome Measure Information:
Title
Rash frequency
Description
Rash frequency in a months
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ranges from 1 to 18 years old; Patients meet the HSP diagnostic criteria; Refractory skin type HSP: Rashes are dense and large in area, often treated with antibiotics, antihistamines, calcium supplements, and glucocorticoids (2 mg/kg/d) for 5 days. The rash does not subside or fresh rash still appears, and frequently repeated more than 3 times during hospitalization. Parents or guardians agree to treatment and sign a written informed consent form. Exclusion Criteria: Individuals who are allergic to leflunomide; Concomitant severe underlying diseases (such as systemic malignancy, heart failure, liver and kidney failure, immune deficiency, severe infectious diseases, organ transplant surgery, or other current indications for emergency surgery); Patients with other digestive system diseases; Those who have previously used flumiphene in clinical trials; Excluding purpura caused by drugs, infectious factors, and other autoimmune diseases. 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiping Tan, PhD
Organizational Affiliation
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Official's Role
Study Chair
Facility Information:
Facility Name
Sun Yat-sen Memorial Hospital, 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
Haiyan Wang, MD
Phone
8613560489257
Email
wanghy78@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Weiping Tan, PhD
Phone
8613556196566
Email
tanwp@mail.sysu.edu.cn

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Leflunomide for Henoch-Schonlein Purpura

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