Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 16
Healthy Volunteers: f
View:

• both genders

• age between 2-16 years old

• IgA vasculitis with gastrointestinal involvement

• course of disease less than 2 months

• refractory to ordinary dosage of prednisolone (less than 2mg/kg/d)

Locations
Other Locations
China
Children's Hospital of Fudan University
RECRUITING
Shanghai
Children's Hospital of Shanghai
NOT_YET_RECRUITING
Shanghai
Shanghai Children's Medical Centre
NOT_YET_RECRUITING
Shanghai
Contact Information
Primary
Li Sun, MD
lillysun@263.com
+8618017590930
Time Frame
Start Date: 2019-09-01
Estimated Completion Date: 2026-10-30
Participants
Target number of participants: 150
Treatments
Experimental: Methylprednisolone group
In this group patients will be given Methylprednisolone pulse(15-30mg/kg/d) and continued with oral prednisolone (2mg/kg/d)
Active_comparator: IVIG group
In this group patients will be given IVIG (2g/kg) and at the same time oral prednisolone (2mg/kg/d)
Sponsors
Collaborators: Shanghai Children's Hospital, Shanghai Children's Medical Center
Leads: Children's Hospital of Fudan University

This content was sourced from clinicaltrials.gov