Clinical trial Recruiting at 1 site Interventional Ages 2 to 16

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.

More Henoch-Schönlein Purpura trials

Quick facts

Study typeInterventional
Ages2 Years to 16 Years
SexAll
Enrollment150 (estimated)
SponsorChildren's Hospital of Fudan University
Academic / other
Locations3 sites (Shanghai and 2 other locations)
StatusRecruiting
StartedSeptember 1, 2019
Main results expectedFebruary 27, 2026
Study endsOctober 30, 2026
Registry record updatedFebruary 19, 2025
Trial IDNCT03647852 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.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.