RECRUITINGINTERVENTIONAL

Leflunomide for Henoch-Schonlein Purpura

Leflunomide for Refractory Skin Henoch-Schonlein Purpura in Children

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form form. Who Should NOT Join This Trial: 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 conditions (where your immune system attacks your own body)s. 6. Other situations where the researcher deems it inappropriate to participate in the study. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

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

Locations (1)

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China