Treatment strategies for severe Henoch-Schönlein Purpura in children
Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura
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
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 2 Years to 16 Years |
| Sex | All |
| Sponsor | Children's Hospital of Fudan University Academic / other |
| Locations | 3 sites (Shanghai and 2 other locations) |
| Trial ID | NCT03647852 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are children aged 2-16 years with IgA vasculitis and gastrointestinal involvement who have not responded to standard prednisolone treatment.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai and 2 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.