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

• Sponsor: The First Hospital of Jilin University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04387942
• Collaborator: (none)
• Enrollment: 59
• Location: 1
• Arms: 2
• Actual Duration (Months): 24.5
• Patients Per Site Per Month: 2.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Purpura, Schoenlein-Henoch	Drug: IL-2	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 59 participants
• Allocation: Non-Randomized
• Intervention Model: Crossover Assignment
• Intervention Model Description: group A:patients were treated with IL-2.group B:patients were not treated with IL-2.group A:patients were treated with IL-2.group B:patients were not treated with IL-2.
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 in Children With Henoch-schönlein Purpura
• Actual Study Start Date: Jun 14, 2020
• Actual Primary Completion Date: May 31, 2022
• Actual Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Recombinant Human Interleukin-2 patients were treated with IL-2.	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.; Other Names: Recombinant Human Interleukin-2 for Injection
No Intervention: Traditional therapy patients were treated with dipyridamole and/or glucocorticoid，immunosuppressor.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 17 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sirui Yang	Changchun	Changchun/JiLin	China	130021

Sponsors and Collaborators

• The First Hospital of Jilin University

Investigators

• Principal Investigator: Yang si rui, MD and PhD, The First Hospital of Jilin University

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.

• Responsible Party: The First Hospital of Jilin University
• ClinicalTrials.gov Identifier: NCT04387942
• Other Study ID Numbers: 20K012-001
• First Posted: May 14, 2020
• Last Update Posted: Aug 18, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by The First Hospital of Jilin University: HSP
• Additional relevant MeSH terms: Purpura, Schoenlein-Henoch; Purpura; Aldesleukin; Interleukin-2

Study Results

No Results Posted as of Aug 18, 2022