Actively Recruiting

Phase Not Applicable
Age: 2Years - 16Years
All Genders
ID03647852

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

Age: 2Years - 16Years
All Genders

Eligibility Criteria

Eligible

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)
Not Eligible

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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

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

Follow-up

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

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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

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