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

Purpura, Schoenlein-Henoch Clinical Trial

— HSP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04387942
• Other study ID #: 20K012-001
• Status: Completed
• Phase: N/A
• Start date: June 14, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: The First Hospital of Jilin University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: June 30, 2022
• Est. primary completion date: May 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Purpura
• Purpura, Schoenlein-Henoch

Intervention

Drug:
• IL-2
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.

Locations

Country	Name	City	State
China	Sirui Yang	Changchun	Changchun/JiLin

Sponsors (1)

Lead Sponsor	Collaborator
The First Hospital of Jilin University

Country where clinical trial is conducted

China, 

References & Publications (4)

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. Epub 2005 Oct 16. Erratum in: Nat Immunol. 2006 Apr;7(4):427. — View Citation

Jen HY, Chuang YH, Lin SC, Chiang BL, Yang YH. Increased serum interleukin-17 and peripheral Th17 cells in children with acute Henoch-Schönlein purpura. Pediatr Allergy Immunol. 2011 Dec;22(8):862-8. doi: 10.1111/j.1399-3038.2011.01198.x. Epub 2011 Sep 19. — View 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. Review. — View Citation

St John J, Vedak P, Garza-Mayers AC, Hoang MP, Nigwekar SU, Kroshinsky D. Location of skin lesions in Henoch-Schönlein 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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