Actively Recruiting

Phase Not Applicable
Age: 1Year - 18Years
All Genders
NCT05937880

Leflunomide for Henoch-Schonlein Purpura

Led by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Updated on 2023-07-10

36

Participants Needed

1

Research Sites

234 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Leflunomide for Henoch-Schonlein Purpura

Who Can Participate

Age: 1Year - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age ranges from 1 to 18 years old
  • Patients meet the HSP diagnostic criteria
  • Refractory skin type HSP with dense, large-area rashes not improving or recurring more than 3 times during hospitalization despite treatment with antibiotics, antihistamines, calcium supplements, and glucocorticoids (2 mg/kg/day) for 5 days
  • Parents or guardians agree to treatment and sign a written informed consent form
Not Eligible

You will not qualify if you...

  • Allergy to leflunomide
  • Severe underlying diseases such as systemic malignancy, heart failure, liver and kidney failure, immune deficiency, severe infections, organ transplant surgery, or current emergency surgery
  • Presence of other digestive system diseases
  • Prior use of flumiphene in clinical trials
  • Purpura caused by drugs, infections, or other autoimmune diseases
  • Other conditions deemed inappropriate for participation by the researcher

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

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

Guangzhou, Guangdong, China, 510120

Actively Recruiting

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Research Team

H

Haiyan Wang, MD

CONTACT

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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Leflunomide for Henoch-Schonlein Purpura | DecenTrialz