Lef for HSP: Leflunomide for Henoch-Schonlein Purpura

Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05937880

Collaborator

(none)

Enrollment

Location

Arm

53.9

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Henoch-Schonlein Purpura	Drug: Leflunomide	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

Refractory skin Henoch-Schonlein PurpuraRefractory skin Henoch-Schonlein Purpura

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Leflunomide for Refractory Skin Henoch-Schonlein Purpura in Children

Actual Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Jun 30, 2027

Anticipated Study Completion Date :

Jun 30, 2027

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Administration of Leflunomide in refractory skin Henoch-Schonlein purpura 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.	Drug: Leflunomide 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

Arm

Intervention/Treatment

Experimental: Administration of Leflunomide in refractory skin Henoch-Schonlein purpura

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.

Drug: Leflunomide

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

Outcome Measures

Primary Outcome Measures

Rash frequency [12 months]
Rash frequency in a months

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 18 Years

Sexes Eligible for Study:

All

Accepts 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.