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

February 25, 2020 updated by: Aihua Zhang, Nanjing Children's Hospital

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210000
        • Recruiting
        • Nanjing Children's Hospital
        • Contact:
          • Aihua Zhang, M.D.
          • Phone Number: +8618951769017
          • Email: bszah@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

2 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Symptoms of Digestive Tract
Time Frame: 2 weeks
The stomachache and other symptoms of digestive tract disappear
2 weeks
The Symptoms of Joint System
Time Frame: 2 weeks
The arthralgia disappears
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Skin Rash
Time Frame: 2 weeks
The Skin Rash disappears
2 weeks
Renal function
Time Frame: 2 weeks
There is no damage in kidney.
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanjing Children's Hospital

Investigators

  • Study Chair: Aihua Zhang, M.D., Department of Nephrology, Nanjing children's hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Anticipated)

July 1, 2020

Study Completion (Anticipated)

July 1, 2020

Study Registration Dates

First Submitted

August 20, 2015

First Submitted That Met QC Criteria

September 1, 2015

First Posted (Estimate)

September 4, 2015

Study Record Updates

Last Update Posted (Actual)

February 26, 2020

Last Update Submitted That Met QC Criteria

February 25, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Zhai

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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