Leflunomide for Henoch-Schonlein Purpura

NCT ID: NCT05937880

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-01
• Study Completion Date: 2027-06-30

Brief Summary

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

Henoch-Schonlein Purpura

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Administration of Leflunomide in refractory skin Henoch-Schonlein purpura

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 new rash still appears, and it frequently repeats more than 3 times during hospitalization.

Group Type: EXPERIMENTAL

Leflunomide

Intervention Type: DRUG

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

Interventions

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

Intervention Type: DRUG

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.

• Minimum Eligible Age: 1 Year
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

OTHER

Sponsor Role: lead

Responsible Party

Weiping Tan

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weiping Tan, PhD

Role: STUDY_CHAIR

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Locations

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

Guangzhou, Guangdong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Haiyan Wang, MD

Role: CONTACT

wanghy78@mail.sysu.edu.cn

+8613560489257

Facility Contacts

Haiyan Wang, MD

Role: primary

wanghy78@mail.sysu.edu.cn

8613560489257

Weiping Tan, PhD

Role: backup

tanwp@mail.sysu.edu.cn

8613556196566

Other Identifiers

2021-KY-002

Identifier Type: -

Identifier Source: org_study_id