The Research of Standard Diagnosis and Treatment for Severe HSP in Children
Primary Purpose
Henoch-Schoenlein Purpura
Status
Unknown status
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Dexamethasone
Gamma globulin
Hemoperfusion
Sponsored by
About this trial
This is an interventional treatment trial for Henoch-Schoenlein Purpura
Eligibility Criteria
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
Sites / Locations
- Nanjing Children's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
group 1
group 2
group 3
Arm Description
Dexamethasone 0.5mg/kg.d i.v.
Dexamethasone & gamma globulin Dexamethasone 0.5mg/kg.d i.v. & gamma globulin i.v. qd*3d, and the total dose is 2g/kg
Dexamethasone & hemoperfusion Dexamethasone 0.5mg/kg.d i.v & hemoperfusion should be given at least three times in five days
Outcomes
Primary Outcome Measures
The Symptoms of Digestive Tract
The stomachache and other symptoms of digestive tract disappear
The Symptoms of Joint System
The arthralgia disappears
Secondary Outcome Measures
The Skin Rash
The Skin Rash disappears
Renal function
There is no damage in kidney.
Full Information
NCT ID
NCT02540720
First Posted
August 20, 2015
Last Updated
February 25, 2020
Sponsor
Nanjing Children's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02540720
Brief Title
The Research of Standard Diagnosis and Treatment for Severe HSP in Children
Official Title
The Research of Standard Diagnosis and Treatment for Severe Henoch-Schonlein Purpura in Children
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
August 2015 (undefined)
Primary Completion Date
July 2020 (Anticipated)
Study Completion Date
July 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Nanjing Children's Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is performed to evaluate the efficacy and safety of various measures in the treatment of severe HSP in children.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Henoch-Schoenlein Purpura
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
group 1
Arm Type
Experimental
Arm Description
Dexamethasone 0.5mg/kg.d i.v.
Arm Title
group 2
Arm Type
Experimental
Arm Description
Dexamethasone & gamma globulin Dexamethasone 0.5mg/kg.d i.v. & gamma globulin i.v. qd*3d, and the total dose is 2g/kg
Arm Title
group 3
Arm Type
Experimental
Arm Description
Dexamethasone & hemoperfusion Dexamethasone 0.5mg/kg.d i.v & hemoperfusion should be given at least three times in five days
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Intervention Type
Drug
Intervention Name(s)
Gamma globulin
Intervention Type
Procedure
Intervention Name(s)
Hemoperfusion
Primary Outcome Measure Information:
Title
The Symptoms of Digestive Tract
Description
The stomachache and other symptoms of digestive tract disappear
Time Frame
2 weeks
Title
The Symptoms of Joint System
Description
The arthralgia disappears
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
The Skin Rash
Description
The Skin Rash disappears
Time Frame
2 weeks
Title
Renal function
Description
There is no damage in kidney.
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aihua Zhang, M.D.
Phone
+8618951769017
Email
bszah@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yimei Wu
Phone
+8615951757930
Email
wym891203@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aihua Zhang, M.D.
Organizational Affiliation
Department of Nephrology, Nanjing children's hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing Children's Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aihua Zhang, M.D.
Phone
+8618951769017
Email
bszah@163.com
12. IPD Sharing Statement
Learn more about this trial
The Research of Standard Diagnosis and Treatment for Severe HSP in Children
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