A Phase 2 interventional study of Dexamethasone and Gamma globulin in Henoch-Schoenlein Purpura, sponsored by Nanjing Children's Hospital. Status unknown at 1 site in China. Open to participants aged 2 Years to 16 Years. Per ClinicalTrials.gov, last updated 2020-02-26.
Sponsored by Nanjing Children's Hospital · Phase 2, Interventional, and Treatment
This study is performed to evaluate the efficacy and safety of various measures in the treatment of severe HSP in children.
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.
36 studies on the registry are indexed under IgA Vasculitis; 12 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 19 interventional studies indexed under IgA Vasculitis.
Browse IgA Vasculitis studies →Nanjing Children's Hospital is the lead sponsor of 16 studies on the registry; 4 are open to participants now.
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Dexamethasone 0.5mg/kg.d i.v.
Drug: Dexamethasone
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
Dexamethasone \& hemoperfusion Dexamethasone 0.5mg/kg.d i.v \& hemoperfusion should be given at least three times in five days
Drug: Dexamethasone · Procedure: Hemoperfusion
The Symptoms of Digestive Tract
The stomachache and other symptoms of digestive tract disappear
Time frame: 2 weeks
The Symptoms of Joint System
The arthralgia disappears
Time frame: 2 weeks
The Skin Rash
The Skin Rash disappears
Time frame: 2 weeks
Renal function
There is no damage in kidney.
Time frame: 2 weeks
The record gives a start of Aug 2015, a primary completion of Jul 2020 and a completion of Jul 2020. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.
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Nanjing Children's Hospital