The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 in Children With Henoch-schönlein Purpura

Study Overview
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Brief Summary
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The study aims to explore the therapeutic value and mechanism of Interleukin-2 on children with Henoch-schönlein purpura.

Detailed Description
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The investigators designed a single center, open-label, prospective study that routinely administered low-dose IL-2 therapy to monitor the improvement of clinical and laboratory parameters to explore its efficacy and to observe changes in immune cell subsets and cytokines.For all patients,rhIL-2(500,000 unit per square meter) infusions seven days;recurrent patients were applied again for 7 days;patients who were diagnosed HSPN were treated on a routine basis for 7 consecutive days, and then once every two week for 3months.

Official Title
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The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 in Children With Henoch-schönlein Purpura

Conditions
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Purpura, Schoenlein-Henoch

Intervention / Treatment
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* Drug: IL-2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age <18 years old meet the EULAR/PRINTO/PRES for the diagnosis of HSP HIV negative;Negative for HBV and HCV. Exclusion Criteria: heart failure (cardiac function ≥ grade III NYHA) liver insufficiency (upper limit of normal range of transaminase > 2 times) renal insufficiency (creatinine clearance ≤30ml/min) acute or severe infections such as bacteremia and sepsis malignant tumor high-dose steroid pulse therapy or intravenous injection of glucocorticoids in the last 1 month mental disorders or any other chronic illness or substance abuse may interfere with the ability to comply with agreements or provide information Intestinal ischemia or perforated gastrointestinal bleeding requires surgery Inability to comply with IL-2 treatment regimen.

Ages Eligible for Study
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Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: group A:patients were treated with IL-2.group B:patients were not treated with IL-2.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Recombinant Human Interleukin-2<br>patients were treated with IL-2. | Drug: IL-2<br>* For all patients,rhIL-2 infusions seven days;recurrent patients was applied again for 7 days;patients who were diagnosed HSPN were treated on a routine basis for 7 consecutive days, and then once every two week for 3months.<br>* Other names: Recombinant Human Interleukin-2 for Injection;|
| No Intervention: Traditional therapy<br>patients were treated with dipyridamole and/or glucocorticoid，immunosuppressor. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of immunological responses | Enumeration of the number of subjects with a change in the absolute number of immune cells and serum cytokines in the peripheral blood | day 0,day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The value of serum immunoglobulins and complements | Laboratory measures were detected, including,serum total IgE, serum Ig A,serum IgG,serum IgM,C3 and C4. | day 0,day 7,3 month,6 month | 
| Incidence of adverse drug reactions | Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event,drug-induced liver and kidney damage. | up to 6 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HSP