The Research of Standard Diagnosis and Treatment for Severe HSP in Children
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|ClinicalTrials.gov Identifier: NCT02540720|
Recruitment Status : Recruiting
First Posted : September 4, 2015
Last Update Posted : August 24, 2018
|Condition or disease||Intervention/treatment||Phase|
|Henoch-Schoenlein Purpura||Drug: Dexamethasone Drug: Gamma globulin Procedure: Hemoperfusion||Phase 2|
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 (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|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|
Experimental: group 1
Dexamethasone 0.5mg/kg.d i.v.
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: 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
- The Symptoms of Digestive Tract [ Time Frame: 2 weeks ]The stomachache and other symptoms of digestive tract disappear
- The Symptoms of Joint System [ Time Frame: 2 weeks ]The arthralgia disappears
- The Skin Rash [ Time Frame: 2 weeks ]The Skin Rash disappears
- Renal function [ Time Frame: 2 weeks ]There is no damage in kidney.
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 ClinicalTrials.gov identifier (NCT number): NCT02540720
|Contact: Aihua Zhang, M.D.||+email@example.com|
|Contact: Yimei Wufirstname.lastname@example.org|
|Nanjing Children's Hospital||Recruiting|
|Nanjing, Jiangsu, China, 210000|
|Contact: Aihua Zhang, M.D. +8618951769017 email@example.com|
|Study Chair:||Aihua Zhang, M.D.||Department of Nephrology, Nanjing children's hospital|