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

Henoch-Schoenlein Purpura Clinical Trial

Official title:

The Research of Standard Diagnosis and Treatment for Severe Henoch-Schonlein Purpura in Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02540720
• Other study ID #: Zhai
• Status: Recruiting
• Phase: Phase 2
• Start date: August 2015
• Est. completion date: July 2020

Study information

• Verified date: February 2020
• Source: Nanjing Children's Hospital
• Contact: Aihua Zhang, M.D.
• Phone: +8618951769017
• Email: bszah[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Henoch-Schoenlein Purpura
• Purpura
• Purpura, Schoenlein-Henoch

Intervention

Drug:
• Dexamethasone

• Gamma globulin

Procedure:
• Hemoperfusion

Locations

Country	Name	City	State
China	Nanjing Children's Hospital	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing Children's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Symptoms of Digestive Tract	The stomachache and other symptoms of digestive tract disappear	2 weeks
Primary	The Symptoms of Joint System	The arthralgia disappears	2 weeks
Secondary	The Skin Rash	The Skin Rash disappears	2 weeks
Secondary	Renal function	There is no damage in kidney.	2 weeks