Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

Recruiting now · Not applicable

Conditions studied: Henoch-Schönlein Purpura

In brief

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.

Key facts

Study ID

NCT03647852

Run by

Children's Hospital of Fudan University

People needed

150

Starts

2019-09-01

Expected to finish

2026-10-30

Last updated by the study team

2025-02-19

Who can join

Age: 2 and older, up to 16. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• both genders
• age between 2-16 years old
• IgA vasculitis with gastrointestinal involvement
• course of disease less than 2 months
• refractory to ordinary dosage of prednisolone (less than 2mg/kg/d）

You may not qualify if…

• patients with severe sepsis
• patients with central nervous system infection,
• patients with severe pneumonia
• patients with chronic infection (such as EBV, CMV, Tuberculosis)
• patients complicated by CKD who need renal replacement therapy
• patients suffering from severe central nervous system complications as intracranial hemorrhage or neuropathy

Where it is running

• Children's Hospital of Fudan University — Shanghai, China (enrolling)
• Children's Hospital of Shanghai — Shanghai, China
• Shanghai Children's Medical Centre — Shanghai, China

Full record on ClinicalTrials.gov

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