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

August 16, 2022 updated by: The First Hospital of Jilin University
The study aims to explore the therapeutic value and mechanism of Interleukin-2 on children with Henoch-schönlein purpura.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

59

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Changchun/JiLin
      • Changchun, Changchun/JiLin, China, 130021
        • Sirui Yang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 17 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The change of immunological responses
Time Frame: 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
day 0,day 7

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The value of serum immunoglobulins and complements
Time Frame: 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.
day 0,day 7,3 month,6 month
Incidence of adverse drug reactions
Time Frame: up to 6 month
Adverse events includes injection site reactions, influenza-like symptoms, infection, fever, tumor, cardiovascular event,drug-induced liver and kidney damage.
up to 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The First Hospital of Jilin University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 14, 2020

Primary Completion (Actual)

May 31, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

May 6, 2020

First Submitted That Met QC Criteria

May 10, 2020

First Posted (Actual)

May 14, 2020

Study Record Updates

Last Update Posted (Actual)

August 18, 2022

Last Update Submitted That Met QC Criteria

August 16, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20K012-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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