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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02540720
Recruitment Status : Recruiting
First Posted : September 4, 2015
Last Update Posted : August 24, 2018
Information provided by (Responsible Party):
Aihua Zhang, 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.

Condition or disease Intervention/treatment Phase
Henoch-Schoenlein Purpura Drug: Dexamethasone Drug: Gamma globulin Procedure: Hemoperfusion Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Research of Standard Diagnosis and Treatment for Severe Henoch-Schonlein Purpura in Children
Study Start Date : August 2015
Estimated Primary Completion Date : July 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. The Symptoms of Digestive Tract [ Time Frame: 2 weeks ]
    The stomachache and other symptoms of digestive tract disappear

  2. The Symptoms of Joint System [ Time Frame: 2 weeks ]
    The arthralgia disappears

Secondary Outcome Measures :
  1. The Skin Rash [ Time Frame: 2 weeks ]
    The Skin Rash disappears

  2. Renal function [ Time Frame: 2 weeks ]
    There is no damage in kidney.

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02540720

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Contact: Aihua Zhang, M.D. +8618951769017
Contact: Yimei Wu +8615951757930

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China, Jiangsu
Nanjing Children's Hospital Recruiting
Nanjing, Jiangsu, China, 210000
Contact: Aihua Zhang, M.D.    +8618951769017   
Sponsors and Collaborators
Nanjing Children's Hospital
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Study Chair: Aihua Zhang, M.D. Department of Nephrology, Nanjing children's hospital

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Responsible Party: Aihua Zhang, Hospital vice president, Nanjing Children's Hospital Identifier: NCT02540720     History of Changes
Other Study ID Numbers: Zhai
First Posted: September 4, 2015    Key Record Dates
Last Update Posted: August 24, 2018
Last Verified: August 2018
Additional relevant MeSH terms:
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Purpura, Schoenlein-Henoch
Blood Coagulation Disorders
Hematologic Diseases
Pathologic Processes
Skin Manifestations
Signs and Symptoms
Vascular Diseases
Cardiovascular Diseases
Hemostatic Disorders
Hemorrhagic Disorders
Immune Complex Diseases
Immune System Diseases
Dexamethasone acetate
BB 1101
Immunoglobulins, Intravenous
Rho(D) Immune Globulin
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents