Study of the Role of Regulator T Cells in the Pathophysiology of Childhood Henoch Schönlein Purpura (NCT02317133) | Clinical Trial Compass
CompletedNot Applicable
Study of the Role of Regulator T Cells in the Pathophysiology of Childhood Henoch Schönlein Purpura
France100 participantsStarted 2015-02
Plain-language summary
The primary objective of this study is to search for evidence of quantitative or functional defects in plasma regulatory T cells (Tregs) in pediatric patients with Henoch Schönlein Purpura (HSP) as compared to a control population.
Who can participate
Age range3 Years – 17 Years
SexALL
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General inclusion criteria for all sub-populations included in the study
* The child (with age- and comprehension-skill-appropriate information) and parents (or persons exercising parental authority) have been informed about the implementation of the study, its objectives, constraints and patient rights
* The child (depending on age) and parents (or persons exercising parental authority) have given their free and informed consent and signed the consent
* The patient must be insured or beneficiary of a health insurance plan
Inclusion criteria for population A: Henoch Schönlein purpura, acute episodes
* The diagnosis of Henoch Schönlein purpura was made by a physician according to the EULAR / PRES / PRINTO 2010 criteria (purpura predominantly on the lower limbs associated with one of the following criteria: abdominal pain, arthralgia or arthritis, kidney damage or suggestive histology (immune deposits dominated by Immunoglobulin A (IgA))
* The patient is not treated via immunosuppression (steroids or other immunosuppressive / biotherapy) and has not been treated like this for at least 15 days
Inclusion criteria for population B: Henoch Schönlein purpura in remission
* The diagnosis of Henoch Schönlein purpura was made by a physician according to the EULAR / PRES / PRINTO 2010 criteria
* The patient has has a Henoch Schönlein purpura episode in the past, and no longer has any symptoms of the disease
* The patient is not treated via immunosuppression (steroids or other immun…
What they're measuring
1
Percentage of blood Tregs
Timeframe: Day 0
2
Absolute Treg count
Timeframe: Day 0
3
Presence / absence of functional abnormality of plasma Tregs