The Research of Standard Diagnosis and Treatment for Severe HSP in Children
1 other identifier
interventional
30
1 country
1
Brief Summary
This study is performed to evaluate the efficacy and safety of various measures in the treatment of severe HSP in children.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2015
Longer than P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2015
CompletedFirst Submitted
Initial submission to the registry
August 20, 2015
CompletedFirst Posted
Study publicly available on registry
September 4, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2020
CompletedFebruary 26, 2020
February 1, 2020
4.9 years
August 20, 2015
February 25, 2020
Conditions
Outcome Measures
Primary Outcomes (2)
The Symptoms of Digestive Tract
The stomachache and other symptoms of digestive tract disappear
2 weeks
The Symptoms of Joint System
The arthralgia disappears
2 weeks
Secondary Outcomes (2)
The Skin Rash
2 weeks
Renal function
2 weeks
Study Arms (3)
group 1
EXPERIMENTALDexamethasone 0.5mg/kg.d i.v.
group 2
EXPERIMENTALDexamethasone \& gamma globulin Dexamethasone 0.5mg/kg.d i.v. \& gamma globulin i.v. qd\*3d, and the total dose is 2g/kg
group 3
EXPERIMENTALDexamethasone \& hemoperfusion Dexamethasone 0.5mg/kg.d i.v \& hemoperfusion should be given at least three times in five days
Interventions
Eligibility Criteria
You may qualify if:
- Severe HSP: could not be controlled with dexamethasone 0.5mg/kg/d or the total dose above 20mg/d for more than two days
You may not qualify if:
- The children with congenital diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nanjing Children's Hospital
Nanjing, Jiangsu, 210000, China
Related Publications (1)
Hahn D, Hodson EM, Craig JC. Interventions for preventing and treating kidney disease in IgA vasculitis. Cochrane Database Syst Rev. 2023 Feb 28;2(2):CD005128. doi: 10.1002/14651858.CD005128.pub4.
PMID: 36853224DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Aihua Zhang, M.D.
Department of Nephrology, Nanjing children's hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Hospital vice president
Study Record Dates
First Submitted
August 20, 2015
First Posted
September 4, 2015
Study Start
August 1, 2015
Primary Completion
July 1, 2020
Study Completion
July 1, 2020
Last Updated
February 26, 2020
Record last verified: 2020-02