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

Not Applicable

Completed

• Conditions: Purpura, Schoenlein-Henoch
• Interventions: Drug: IL-2

• Registration Number: NCT04387942
• Lead Sponsor: The First Hospital of Jilin University

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2020-05-06
• Study First Submitted QC: 2020-05-10
• Study First Posted: 2020-05-14
• Study Start: 2020-06-14
• Primary Completion: 2022-05-31
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-16
• Last Update Posted: 2022-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

1. age <18 years old
2. meet the EULAR/PRINTO/PRES for the diagnosis of HSP
3. HIV negative;Negative for HBV and HCV.

Exclusion Criteria

1. heart failure (cardiac function ≥ grade III NYHA)
2. liver insufficiency (upper limit of normal range of transaminase > 2 times)
3. renal insufficiency (creatinine clearance ≤30ml/min)
4. acute or severe infections such as bacteremia and sepsis
5. malignant tumor
6. high-dose steroid pulse therapy or intravenous injection of glucocorticoids in the last 1 month
7. mental disorders or any other chronic illness or substance abuse may interfere with the ability to comply with agreements or provide information
8. Intestinal ischemia or perforated gastrointestinal bleeding requires surgery
9. Inability to comply with IL-2 treatment regimen.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Recombinant Human Interleukin-2	IL-2	patients were treated with IL-2.

Primary Outcome Measures

Name	Time	Method
The change of immunological responses	day 0,day 7	Enumeration of the number of subjects with a change in the absolute number of immune cells and serum cytokines in the peripheral blood

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Sirui Yang; 🇨🇳 Changchun, Changchun/JiLin, China