Leflunomide for Henoch-Schonlein Purpura

Launched by SUN YAT-SEN MEMORIAL HOSPITAL OF SUN YAT-SEN UNIVERSITY · Jul 1, 2023

Keywords

ClinConnect Summary

This clinical trial is studying the use of a medication called leflunomide, combined with steroid therapy, to treat children with a condition known as Henoch-Schonlein Purpura (HSP) that affects the skin and does not respond well to standard treatments. The goal is to see if this combination treatment can help reduce the frequency of skin rashes and improve overall health in children aged 1 to 18 who have severe skin symptoms of HSP. Researchers will follow the participants for one year to monitor how well the treatment works and if it is safe.

To be eligible for this trial, children must be between 1 and 18 years old and diagnosed with HSP that is not improving with other treatments. They should have significant skin rashes that have not subsided despite previous treatments. Parents or guardians will need to agree to the treatment and sign a consent form. It’s important to note that children with certain health issues or allergies to leflunomide cannot participate. This study hopes to offer new treatment options for children suffering from this challenging condition.

Gender

ALL

Eligibility criteria

• 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.