NCT05937880

Leflunomide for Henoch-Schonlein Purpura

Leflunomide for Refractory Skin Henoch-Schonlein Purpura in Children

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: 1 Year – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Henoch-Schonlein Purpura

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-01-01
• Primary completion: 2027-06-30
• Completion: 2027-06-30
• First posted: 2023-07-10
• Last updated: 2023-07-10

Locations

1 site across 1 country: China