Actively Recruiting
Leflunomide for Refractory Skin Henoch-Schonlein Purpura in Children
Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2023-07-10
36
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the use of leflunomide combined with steroid therapy to treat children with refractory skin Henoch-Schonlein Purpura (HSP), a condition characterized by dense, large-area rashes that do not improve with standard treatments. This prospective, multicenter clinical trial aims to explore the safety and effectiveness of adding leflunomide to conventional therapy, with a one-year follow-up to monitor key health indicators. Children in this study will receive leflunomide after showing persistent or recurrent rashes despite treatment with antibiotics, antihistamines, calcium supplements, and glucocorticoids (at a dose of 2 mg/kg per day for 5 days). The study focuses on those whose rash recurs more than three times during hospitalization. Leflunomide is administered alongside the conventional treatment as part of a single-arm trial. Participants will be monitored over 12 months to track changes in rash recurrence frequency, kidney involvement, joint symptoms, T lymphocyte subpopulations, and inflammatory factors. Researchers will assess safety and treatment responses through clinical observations and laboratory measures during this period. The total participation time covers the treatment phase and one year of follow-up to evaluate lasting effects.
CONDITIONS
Brief Title
Leflunomide for Henoch-Schonlein Purpura
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age ranges from 1 to 18 years old
- Diagnosis of Henoch-Schonlein Purpura
- Refractory skin type HSP with dense, large-area rashes not improving after 5 days of antibiotics, antihistamines, calcium supplements, and glucocorticoids (2 mg/kg/d)
- Rash recurs more than 3 times during hospitalization
- Parents or guardians agree to treatment and sign informed consent
You will not qualify if you...
- Allergy to leflunomide
- Severe underlying diseases such as malignancy, heart failure, liver or kidney failure, immune deficiency, severe infections, organ transplant, or emergency surgery
- Other digestive system diseases
- Previous use of flumiphene in clinical trials
- Purpura caused by drugs, infections, or other autoimmune diseases
- Any condition deemed inappropriate for participation by the researcher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Duration of Leflunomide treatment as needed during hospitalization
Participants receive Leflunomide for refractory skin Henoch-Schonlein Purpura after initial treatment with antibiotics, antihistamines, calcium supplements, and glucocorticoids for 5 days when rashes do not subside or frequently recur.
Trial Site Locations
Total: 1 location
1
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510120
Actively Recruiting
Research Team
H
Haiyan Wang, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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