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NCT Number: NCT05937880

Leflunomide for Henoch-Schonlein Purpura

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.

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Key information

Conditions

Henoch-Schonlein Purpura Blood Coagulation Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Hypersensitivity IgA Vasculitis Immune Complex Diseases Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin Manifestations Skin and Connective Tissue Diseases Vascular Diseases Vasculitis

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ranges from 1 to 18 years old;
  • Patients meet the HSP diagnostic criteria;
  • 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.
  • Parents or guardians agree to treatment and sign a written informed consent form.

Exclusion criteria

  • Individuals who are allergic to leflunomide;
  • 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);
  • Patients with other digestive system diseases;
  • Those who have previously used flumiphene in clinical trials;
  • Excluding purpura caused by drugs, infectious factors, and other autoimmune diseases.
  • Other situations where the researcher deems it inappropriate to participate in the study.

Treatment and study plan

leflunomide

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

Primary outcomes

  1. Rash frequency

    Time frame: 12 months

    Rash frequency in a months

Study contacts

Contact information is provided by the study sponsor or research team.

Haiyan Wang, MD

CONTACT

[email protected]

+8613560489257

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Leflunomide for Refractory Skin Henoch-Schonlein Purpura in Children

Acronym: Lef for HSP

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Jul 10, 2023
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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