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

Primary Purpose

Purpura, Schoenlein-Henoch

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
IL-2
Sponsored by
The First Hospital of Jilin University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Purpura, Schoenlein-Henoch focused on measuring HSP

Eligibility Criteria

undefined - 17 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Sirui Yang

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Recombinant Human Interleukin-2

Traditional therapy

Arm Description

patients were treated with IL-2.

patients were treated with dipyridamole and/or glucocorticoid，immunosuppressor.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.

Full Information

First Posted
May 6, 2020
Last Updated
August 16, 2022
Sponsor
The First Hospital of Jilin University
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1. Study Identification

Unique Protocol Identification Number
NCT04387942
Brief Title
The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 in Children With Henoch-schönlein Purpura
Acronym
HSP
Official Title
The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 in Children With Henoch-schönlein Purpura
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
June 14, 2020 (Actual)
Primary Completion Date
May 31, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The First Hospital of Jilin University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Purpura, Schoenlein-Henoch
Keywords
HSP

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
group A:patients were treated with IL-2.group B:patients were not treated with IL-2.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Recombinant Human Interleukin-2
Arm Type
Experimental
Arm Description
patients were treated with IL-2.
Arm Title
Traditional therapy
Arm Type
No Intervention
Arm Description
patients were treated with dipyridamole and/or glucocorticoid，immunosuppressor.
Intervention Type
Drug
Intervention Name(s)
IL-2
Other Intervention Name(s)
Recombinant Human Interleukin-2 for Injection
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of immunological responses
Description
Enumeration of the number of subjects with a change in the absolute number of immune cells and serum cytokines in the peripheral blood
Time Frame
day 0,day 7
Secondary Outcome Measure Information:
Title
The value of serum immunoglobulins and complements
Description
Laboratory measures were detected, including,serum total IgE, serum Ig A,serum IgG,serum IgM,C3 and C4.
Time Frame
day 0,day 7,3 month,6 month
Title
Incidence of adverse drug reactions
Description
Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event,drug-induced liver and kidney damage.
Time Frame
up to 6 month

10. Eligibility

Sex
All
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yang si rui, MD and PhD
Organizational Affiliation
The First Hospital of Jilin University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sirui Yang
City
Changchun
State/Province
Changchun/JiLin
ZIP/Postal Code
130021
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29241772
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.
Results Reference
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PubMed Identifier
21929599
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.
Results Reference
background
PubMed Identifier
16227984
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. Erratum In: Nat Immunol. 2006 Apr;7(4):427.
Results Reference
background
PubMed Identifier
29677473
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.
Results Reference
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The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 in Children With Henoch-schönlein Purpura

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