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

The Research of Standard Diagnosis and Treatment for Severe Henoch-Schonlein Purpura in Children

Status
UNKNOWN
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02540720
Enrollment
30
Registered
2015-09-04
Start date
2015-08-31
Completion date
2020-07-31
Last updated
2020-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Henoch-Schoenlein Purpura

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.

Interventions

DRUGDexamethasone
PROCEDUREHemoperfusion

Sponsors

Nanjing Children's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
2 Years to 16 Years
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

Design outcomes

Primary

MeasureTime frameDescription
The Symptoms of Digestive Tract2 weeksThe stomachache and other symptoms of digestive tract disappear
The Symptoms of Joint System2 weeksThe arthralgia disappears

Secondary

MeasureTime frameDescription
The Skin Rash2 weeksThe Skin Rash disappears
Renal function2 weeksThere is no damage in kidney.

Countries

China

Contacts

Primary ContactAihua Zhang, M.D.
bszah@163.com+8618951769017
Backup ContactYimei Wu
wym891203@163.com+8615951757930

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026