Clinical trial NCT04387942: The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 in Children With Henoch-schönlein Purpura
Official title: The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 in Children With Henoch-schönlein Purpura
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Purpura, Schoenlein-Henoch
Keywords: HSP
Lead sponsor: The First Hospital of Jilin University
Sponsor class: OTHER
First posted: 2020-05-14
Enrollment: 59
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: group A:patients were treated with IL-2.group B:patients were not treated with IL-2.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The change of immunological responses
timeFrame: day 0,day 7
Secondary outcomes:
measure: The value of serum immunoglobulins and complements
timeFrame: day 0,day 7,3 month,6 month
measure: Incidence of adverse drug reactions
timeFrame: up to 6 month
Other outcomes:
Locations:
city: Changchun
country: China
facility: Sirui Yang
state: Changchun/JiLin
Study officials:
affiliation: The First Hospital of Jilin University
name: Yang si rui, MD and PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: St John J, Vedak P, Garza-Mayers AC, Hoang MP, Nigwekar SU, Kroshinsky D. Location of skin lesions in Henoch-Schonlein purpura and its association with significant renal involvement. J Am Acad Dermatol. 2018 Jan;78(1):115-120. doi: 10.1016/j.jaad.2017.04.1122.
citation: Jen HY, Chuang YH, Lin SC, Chiang BL, Yang YH. Increased serum interleukin-17 and peripheral Th17 cells in children with acute Henoch-Schonlein purpura. Pediatr Allergy Immunol. 2011 Dec;22(8):862-8. doi: 10.1111/j.1399-3038.2011.01198.x. Epub 2011 Sep 19.
citation: Fontenot JD, Rasmussen JP, Gavin MA, Rudensky AY. A function for interleukin 2 in Foxp3-expressing regulatory T cells. Nat Immunol. 2005 Nov;6(11):1142-51. doi: 10.1038/ni1263. Epub 2005 Oct 16.
citation: Ross SH, Cantrell DA. Signaling and Function of Interleukin-2 in T Lymphocytes. Annu Rev Immunol. 2018 Apr 26;36:411-433. doi: 10.1146/annurev-immunol-042617-053352.