Clinical Study on Strategy for Refractory Henoch-Schönlein Purpura

Fudan University

Status: Enrolling

Conditions: Henoch-Schönlein Purpura

Treatments: Drug: IVIG; Drug: Methylprednisolone; Drug: other basic supportive treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03647852

chfuHSP 1.0

Details and patient eligibility

About

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.

Enrollment: 150 estimated patients

Sex: All

Ages: 2 to 16 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Methylprednisolone group

Experimental group

Description:

In this group patients will be given Methylprednisolone pulse(15-30mg/kg/d) and continued with oral prednisolone (2mg/kg/d)

Treatment:

Drug: other basic supportive treatment

Drug: Methylprednisolone

IVIG group

Active Comparator group

Description:

In this group patients will be given IVIG (2g/kg) and at the same time oral prednisolone (2mg/kg/d)

Treatment:

Drug: other basic supportive treatment

Drug: IVIG