Using leflunomide to treat skin Henoch-Schonlein Purpura in children

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness of leflunomide combined with steroid therapy for children suffering from refractory skin Henoch-Schonlein Purpura (HSP). It is a prospective, multicenter, one-arm trial that follows participants for one year to assess changes in rash recurrence and other health indicators. The study aims to determine the safety and efficacy of leflunomide in improving remission rates and reducing recurrence of skin purpura in affected children. The results could lead to new treatment strategies for this condition.

Why it matters

Who can join: the full rules

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.

Where it's running

• Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  Guangzhou, Guangdong, China Recruiting

Study contacts

• Study coordinator: Haiyan Wang, MD
• Email: wanghy78@mail.sysu.edu.cn
• Phone: +8613560489257

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.