Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

Not Applicable

Recruiting

• Conditions: Henoch-Schönlein Purpura
• Interventions: Drug: Methylprednisolone; Drug: IVIG; Drug: other basic supportive treatment

• Registration Number: NCT03647852
• Lead Sponsor: Children's Hospital of Fudan University

Brief Summary

IgA vasculitis is relatively common in children,especially in Asian countries. Abdominal manifestation could be severe, including bleeding, pancreatitis,appendicitis and intestinal intussusception. Delayed diagnosis could be fatal and cause severe complications.Nowadays no guidelines for those with severe abdominal manifestations in China.However, the most used treatment is steroid. For those severe forms are methylprednisolone pulse, IVIG, immunosuppressants and blood purification. Given the fact that different strategies lead to different endings which varies in cost, adverse effect and clinical outcomes in different medical centers, it is necessary to give birth to a useful and feasible strategy. This clinical trial is a muti-center, randomized,controlled prospective study.Patients with gastrointestinal disease will be recruited in three children's medical centres in Shanghai and will be randomized to two groups: MP group and IVIG group. Cost effect and clinical outcomes will be evaluated. Blood purification will be evaluated as a remedy when MP and IVIG fail to cure.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-22
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-27
• Study Start: 2019-09-01
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-18
• Last Update Posted: 2025-02-19
• Primary Completion: 2026-02-27
• Study Completion: 2026-10-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methylprednisolone group	Methylprednisolone	In this group patients will be given Methylprednisolone pulse(15-30mg/kg/d) and continued with oral prednisolone (2mg/kg/d)
Methylprednisolone group	other basic supportive treatment	In this group patients will be given Methylprednisolone pulse(15-30mg/kg/d) and continued with oral prednisolone (2mg/kg/d)
IVIG group	other basic supportive treatment	In this group patients will be given IVIG (2g/kg) and at the same time oral prednisolone (2mg/kg/d)
IVIG group	IVIG	In this group patients will be given IVIG (2g/kg) and at the same time oral prednisolone (2mg/kg/d)

Primary Outcome Measures

Name	Time	Method
sustained abdominal pain relief	3 days after treatment	no abdominal pain complaint and no abdominal tenderness

Secondary Outcome Measures

Name	Time	Method
hypertension	7 days after treatment	systolic or diastolic blood pressure greater than or equal to 95% for the age, sex, and height of the patient is considered to have 1.hypertension otherwise 0. Blood pressure will be measured with mercury blood pressure monitor.
The number of days in hospital	at the time of discharge	The number of days in hospital will be counted at the time of discharge
sustained abdominal pain relief	7 days after treatment	3 days after treatment part of the patients may fail the first assigned intervention and has to accept the alternative intervention and abdominal pain complaint and abdominal tenderness will be checked at 7 days after treatment
the number of days of taking fasting	At the time of discharge	the number of days of taking fasting will be counted at the time of discharge
steroid-related diabetes	3 days after treatment	1. with steroid-related diabetes 0. no steroid-related diabetes . Steroid-related diabetes will be defined as random blood sugar is greater than 11.1 mmol/l
cost of treatment	4 weeks after treatment	cost of treatment will be obtained from discharge fee list
other treatment rather than assigned intervention	4 weeks after treatment	other treatment such as blood purification, the second methylprednisolone pulse, and immunosuppressant will be documented if the two interventions all failed
Drug-related side effects	3 days after treatment	Side effects associated with methylprednisolone and IVIG will be recorded
tolarable food type	2 weeks after treatment	what kind of food can be tolerant ( 0 fluid, 1 semi liquid, 2 solid )
infection	4 weeks after treatment	different infection types should be specified
ocular hypertension	7 days after treatment	1.ocular hypertension 0. no ocular hypertension. Ocular hypertension will be defined as intraocular pressure of either eye is greater greater or equal to 21mmHg

Trial Locations

Locations (3)

Shanghai Children's Medical Centre; 🇨🇳 Shanghai, China

Children's Hospital of Shanghai; 🇨🇳 Shanghai, China

Children's Hospital of Fudan University; 🇨🇳 Shanghai, China