Clinical Trial

Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

Recruiting
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Record status
This record was last updated February 19, 2025 (before its estimated February 27, 2026 completion). Its status may not reflect the trial's current state.
Summary
IgA vasculitis is relatively common in children,especially in Asian countries. Abdominal manifestation could be severe, including bleeding, pancreatitis,appendicitis and intestinal intussusception. Delayed diagnosis could be fatal and cause severe complications.Nowadays no guidelines for those with severe abdominal manifestations in China.However, the most used treatment is steroid. For those severe forms are methylprednisolone pulse, IVIG, immunosuppressants and blood purification. Given the fact that different strategies lead to different endings which varies in cost, adverse effect and clinical outcomes in different medical centers, it is necessary to give birth to a useful and feasible strategy. This clinical trial is a muti-center, randomized,controlled prospective study.Patients with gastrointestinal disease will be recruited in three children's medical centres in Shanghai and will be randomized to two groups: MP group and IVIG group. Cost effect and clinical outcomes will be evaluated. Blood purification will be evaluated as a remedy when MP and IVIG fail to cure.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2018-08-23; most recent amendment 2025-02-18.
Status change: Not Yet Recruiting → Recruiting 2019-11-11
Trial Details
NCT Number NCT03647852
Lead Sponsor Children's Hospital of Fudan University
Collaborators: Shanghai Children's Hospital, Shanghai Children's Medical Center
Conditions Henoch-Schönlein Purpura
Enrollment 150 participants
Start Date 2019-09-01
Primary Completion 2026-02-27 (estimated)
Study Completion 2026-10-30 (estimated)
Updated on ClinicalTrials.gov 2025-02-19