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CompletedNCT04387942HSPUpdated Aug 18, 2022

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

An interventional study of IL-2 in Purpura, Schoenlein-Henoch, sponsored by The First Hospital of Jilin University. Completed at 1 site in China. Open to participants aged Up to 17 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-08-18.

Sponsored by The First Hospital of Jilin University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
59
Allocation
Non-randomized
Ages
Up to 17 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Purpura, Schoenlein-Henoch

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Keywords

  • HSP
03

In context

IgA Vasculitis

36 studies on the registry are indexed under IgA Vasculitis; 12 are open to participants now.

This study's enrollment of 59 is close to the median of 60 across 19 interventional studies indexed under IgA Vasculitis.

Browse IgA Vasculitis studies →

Lead sponsor

The First Hospital of Jilin University is the lead sponsor of 185 studies on the registry; 96 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  1. heart failure (cardiac function ≥ grade III )
  2. liver insufficiency ( of transaminase > 2 times)
  3. renal insufficiency ( ≤30ml/min)
  4. acute or severe infections such as bacteremia and sepsis
  5. malignant tumor
  6. high-dose 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.
Terms in these criteria, in plain language(7)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Hepatitis C tests

Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.

After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

ULN (upper limit of normal)

The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.

“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.

Creatinine clearance (CrCl)

How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
59 participants (actual)

Study arms

  • Experimental
    Recombinant Human Interleukin-2

    patients were treated with IL-2.

    Drug: IL-2

  • No intervention
    Traditional therapy

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

Interventions

  • DrugIL-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.

    Also known as: Recombinant Human Interleukin-2 for Injection

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: day 0,day 7

Secondary outcomes

  1. 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.

    Time frame: day 0,day 7,3 month,6 month

  2. 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.

    Time frame: up to 6 month

07

Study locations

1 site
  • Sirui Yang
    Changchun, Changchun/JiLin 130021, China
08

References and documents

Publications

  • 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. PubMed 29241772 ↗
  • 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. PubMed 21929599 ↗
  • 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. PubMed 16227984 ↗
  • 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. PubMed 29677473 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04387942
Responsible party
Sponsor
First posted
May 14, 2020
Start date
Jun 14, 2020
Primary completion
May 31, 2022
Completion
Jun 30, 2022
Last update
Aug 18, 2022

Study contacts

Yang si rui, MD and PhD
principal investigator · The First Hospital of Jilin University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Interleukin-2

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