Treatment strategies for severe Henoch-Schönlein Purpura in children
Official title: Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura
Run by Children's Hospital of Fudan University · NCT03647852 · Data updated 2026-11-12
This study tests whether giving children with severe Henoch-Schönlein Purpura either a steroid or an immune treatment helps them feel better and manage their stomach problems.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 2 Years to 16 Years |
| Sex | All |
| Enrollment | 150 (estimated) |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 3 sites (Shanghai and 2 other locations) |
| Status | Recruiting |
| Started | September 1, 2019 |
| Main results expected | February 27, 2026 |
| Study ends | October 30, 2026 |
| Registry record updated | February 19, 2025 |
| Trial ID | NCT03647852 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are children aged 2-16 years with IgA vasculitis and gastrointestinal involvement who have not responded to standard prednisolone treatment.
✕Probably not a fit
Patients with severe infections, chronic conditions requiring renal replacement therapy, or severe central nervous system complications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial investigates treatment strategies for children aged 2-16 years with IgA vasculitis and severe gastrointestinal involvement. It is a multi-center, randomized, controlled prospective study conducted in three children's medical centers in Shanghai. Participants will be divided into two groups receiving either methylprednisolone or intravenous immunoglobulin (IVIG) to evaluate the cost-effectiveness and clinical outcomes of each treatment approach. The study aims to establish a feasible strategy for managing severe abdominal manifestations of this condition.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment strategy for children suffering from severe gastrointestinal complications of Henoch-Schönlein Purpura.
How similar studies have gone: While there is limited data on similar studies, the approach of comparing treatment strategies for severe forms of IgA vasculitis is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. both genders 2. age between 2-16 years old 3. IgA vasculitis with gastrointestinal involvement 4. course of disease less than 2 months 5. refractory to ordinary dosage of prednisolone (less than 2mg/kg/d) Exclusion Criteria: 1. patients with severe sepsis 2. patients with central nervous system infection, 3. patients with severe pneumonia 4. patients with chronic infection (such as EBV, CMV, Tuberculosis) 5. patients complicated by CKD who need renal replacement therapy 6. patients suffering from severe central nervous system complications as intracranial hemorrhage or neuropathy
Where it's running
-
Children's Hospital of Fudan University
Shanghai, China Recruiting -
Children's Hospital of Shanghai
Shanghai, China Not yet recruiting -
Shanghai Children's Medical Centre
Shanghai, China Not yet recruiting
Study contacts
- Principal investigator: Li Sun, MD — Children's Hospital of Fudan University
- Study coordinator: Li Sun, MD
- Email: lillysun@263.com
- Phone: +8618017590930
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Using Mycophenolate Mofetil for Gastrointestinal Issues in Children with Henoch-Schönlein Purpura
This study tests if a medication called Mycophenolate Mofetil can help children aged 3 to 18 with stubborn stomach problems caused by Henoch-Schönlein Purpura when other treatments haven't worked.
-
Comparing treatments for isolated skin vasculitis
This study is testing which of three common treatments—colchicine, dapsone, or azathioprine—works best for people with isolated skin vasculitis over a year.
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Personalized IgA Nephropathy treatment guided by Gd-IgA1 monitoring
This study tests whether regularly checking a biomarker called Gd-IgA1 to guide treatment with Nefecon or telitacicept helps people with IgA nephropathy or related nephritis respond better.
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Finerenone treatment for children with Henoch–Schönlein purpura nephritis and mild proteinuria
This trial will test whether adding finerenone to standard ACEI/ARB therapy helps reduce protein in the urine and is safe for children aged 3 to 17 with HSPN and mild proteinuria.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.