Leflunomide for Henoch-Schonlein Purpura

Not Applicable

Recruiting

• Conditions: Henoch-Schonlein Purpura
• Interventions: Drug: Leflunomide

• Registration Number: NCT05937880
• Lead Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-01-01
• Study First Submitted: 2023-06-25
• Status Verified: 2023-07
• Study First Submitted QC: 2023-07-01
• Last Update Submitted: 2023-07-01
• Study First Posted: 2023-07-10
• Last Update Posted: 2023-07-10
• Primary Completion: 2027-06-30
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Age ranges from 1 to 18 years old;
2. Patients meet the HSP diagnostic criteria;
3. 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.
4. Parents or guardians agree to treatment and sign a written informed consent form.

Exclusion Criteria

1. Individuals who are allergic to leflunomide;
2. 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);
3. Patients with other digestive system diseases;
4. Those who have previously used flumiphene in clinical trials;
5. Excluding purpura caused by drugs, infectious factors, and other autoimmune diseases.
6. Other situations where the researcher deems it inappropriate to participate in the study.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Administration of Leflunomide in refractory skin Henoch-Schonlein purpura	Leflunomide	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.

Primary Outcome Measures

Name	Time	Method
Rash frequency	12 months	Rash frequency in a months

Trial Locations

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University; 🇨🇳 Guangzhou, Guangdong, China