NCT04387942

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
59

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 6, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 14, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

June 14, 2020

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 18, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

May 6, 2020

Last Update Submit

August 16, 2022

Conditions

Purpura, Schoenlein-Henoch

Keywords

HSP

Outcome Measures

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

    day 0,day 7

Secondary Outcomes (2)

  • The value of serum immunoglobulins and complements

    day 0,day 7,3 month,6 month

  • Incidence of adverse drug reactions

    up to 6 month

Study Arms (2)

Recombinant Human Interleukin-2

EXPERIMENTAL

patients were treated with IL-2.

Drug: IL-2

Traditional therapy

NO INTERVENTION

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

Interventions

IL-2DRUG

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
Recombinant Human Interleukin-2

Eligibility Criteria

AgeUp to 17 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • age \<18 years old
  • meet the EULAR/PRINTO/PRES for the diagnosis of HSP
  • HIV negative;Negative for HBV and HCV.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sirui Yang

Changchun, Changchun/JiLin, 130021, China

Location

Related Publications (4)

  • 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.

    PMID: 29241772BACKGROUND

  • 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.

    PMID: 21929599BACKGROUND

  • 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.

    PMID: 16227984BACKGROUND

  • 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.

    PMID: 29677473BACKGROUND

MeSH Terms

Conditions

IgA Vasculitis

Interventions

Interleukin-2aldesleukinInjections

Condition Hierarchy (Ancestors)

VasculitisVascular DiseasesCardiovascular DiseasesPurpuraBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesHemostatic DisordersHemorrhagic DisordersSkin Diseases, VascularSkin DiseasesSkin and Connective Tissue DiseasesImmune Complex DiseasesHypersensitivityImmune System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsSkin ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

InterleukinsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsLymphokinesProteinsBiological FactorsDrug Administration RoutesDrug TherapyTherapeutics

Study Officials

  • Yang si rui, MD and PhD

    The First Hospital of Jilin University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: group A:patients were treated with IL-2.group B:patients were not treated with IL-2.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 6, 2020

First Posted

May 14, 2020

Study Start

June 14, 2020

Primary Completion

May 31, 2022

Study Completion

June 30, 2022

Last Updated

August 18, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)