Actively Recruiting
Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura in Children with Gastrointestinal Involvement
Led by Children's Hospital of Fudan University · Updated on 2025-02-19
150
Participants Needed
3
Research Sites
35 weeks
Total Duration
On this page
Sponsors
C
Children's Hospital of Fudan University
Lead Sponsor
S
Shanghai Children's Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
IgA vasculitis is a condition that commonly affects children, particularly in Asian countries, and can cause serious abdominal problems like bleeding, pancreatitis, appendicitis, and intestinal intussusception. Delayed diagnosis may lead to severe complications or fatal outcomes. This trial aims to evaluate and compare treatment strategies for children with severe abdominal symptoms caused by IgA vasculitis, focusing on cost-effectiveness and clinical results. It is a multi-center, randomized, and controlled prospective study conducted in three children's medical centers in Shanghai. Participants will be randomly assigned to one of two treatment groups: one group receives methylprednisolone pulse therapy (15-30 mg/kg per day) for three days followed by oral prednisolone (2 mg/kg per day), while the other group receives intravenous immunoglobulin (IVIG) at 2 g/kg along with oral prednisolone at 2 mg/kg per day. If abdominal pain persists after three days, the treatment may switch to the alternate therapy. Supportive treatments such as omeprazole and low molecular weight heparin calcium are also provided. Blood purification treatment will be considered if both primary therapies fail to relieve symptoms. During the study, participants will be monitored for abdominal pain relief at 3 and 7 days after treatment, medication side effects, infection, hypertension, ocular hypertension, steroid-related diabetes, and hospital stay length. Researchers will also evaluate food tolerance, fasting duration, and treatment costs. The total participation duration includes follow-up assessments up to 4 weeks after treatment to track these outcomes and assess the safety and effectiveness of the treatment strategies.
CONDITIONS
Brief Title
Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Both genders
- Age between 2 and 16 years old
- Diagnosis of IgA vasculitis with gastrointestinal involvement
- Disease duration less than 2 months
- Not responding to ordinary doses of prednisolone (less than 2 mg/kg per day)
You will not qualify if you...
- Severe sepsis
- Central nervous system infection
- Severe pneumonia
- Chronic infections such as EBV, CMV, or Tuberculosis
- Chronic kidney disease requiring renal replacement therapy
- Severe central nervous system complications like intracranial hemorrhage or neuropathy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - At least 3 days with continued oral prednisolone
Participants receive assigned drug treatments involving methylprednisolone pulse therapy or IVIG combined with oral prednisolone. Supportive treatments such as omeprazole and low molecular weight heparin calcium are also provided. Treatment adjustments may occur on the third day based on symptom response.
Daily visits for up to 3 days
Duration - Up to 4 weeks after treatment
Participants are monitored for abdominal pain relief, side effects, and other health outcomes up to 4 weeks after treatment.
Visits at 3 days, 7 days, 2 weeks, and 4 weeks post-treatment
Trial Site Locations
Total: 3 locations
1
Children's Hospital of Fudan University
Shanghai, China
Actively Recruiting
2
Children's Hospital of Shanghai
Shanghai, China
Not Yet Recruiting
3
Shanghai Children's Medical Centre
Shanghai, China
Not Yet Recruiting
Research Team
L
Li Sun, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2