The Research of Standard Diagnosis and Treatment for Severe HSP in Children

Phase 2

• Conditions: Henoch-Schoenlein Purpura
• Interventions: Drug: Dexamethasone; Drug: Gamma globulin; Procedure: Hemoperfusion

• Registration Number: NCT02540720
• Lead Sponsor: Nanjing Children's Hospital

Brief Summary

This study is performed to evaluate the efficacy and safety of various measures in the treatment of severe HSP in children.

Detailed Description

Henoch-Schonlein purpura (HSP) is a systemic vasculitis affecting small vessels with immunoglobulin A (IgA)-dominant immune deposits. The clinical manifestations of severe HSP vary from massive hemorrhage and necrosis of the skin to severe gastrointestinal symptoms. The course of the disease would encounter delay and relapse. To some extent, the traditional therapy alleviate the clinical symptoms, but fail to timely clear up the immune depositions, causing the damage to the kidney.

In the study, the patients will be given dexamethasone 0.5mg/kg/d, then be randomised to receive either gamma globulin i.v. or hemoperfusion if the disease can't be controlled with steroid treatment for more than two days.

The investigators will explore the biological markers and compare the efficacy and safety of both measures in the treatment of serve HSP in children. The purpose of the study is to optimize the treatment of severe HSP for children with different ages.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-20
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-04
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-25
• Last Update Posted: 2020-02-26
• Primary Completion: 2020-07
• Study Completion: 2020-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Severe HSP: could not be controlled with dexamethasone 0.5mg/kg/d or the total dose above 20mg/d for more than two days

Exclusion Criteria

• The children with congenital diseases

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
group 2	Dexamethasone	Dexamethasone \& gamma globulin Dexamethasone 0.5mg/kg.d i.v. \& gamma globulin i.v. qd\*3d, and the total dose is 2g/kg
group 2	Gamma globulin	Dexamethasone \& gamma globulin Dexamethasone 0.5mg/kg.d i.v. \& gamma globulin i.v. qd\*3d, and the total dose is 2g/kg
group 1	Dexamethasone	Dexamethasone 0.5mg/kg.d i.v.
group 3	Dexamethasone	Dexamethasone \& hemoperfusion Dexamethasone 0.5mg/kg.d i.v \& hemoperfusion should be given at least three times in five days
group 3	Hemoperfusion	Dexamethasone \& hemoperfusion Dexamethasone 0.5mg/kg.d i.v \& hemoperfusion should be given at least three times in five days

Primary Outcome Measures

Name	Time	Method
The Symptoms of Digestive Tract	2 weeks	The stomachache and other symptoms of digestive tract disappear
The Symptoms of Joint System	2 weeks	The arthralgia disappears

Secondary Outcome Measures

Name	Time	Method
The Skin Rash	2 weeks	The Skin Rash disappears
Renal function	2 weeks	There is no damage in kidney.

Trial Locations

Locations (1)

Nanjing Children's Hospital; 🇨🇳 Nanjing, Jiangsu, China