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NCT Number: NCT04387942

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

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

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Key information

Conditions

Purpura, Schoenlein-Henoch Blood Coagulation Disorders Cardiovascular Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhage Hemorrhagic Disorders Hemostatic Disorders Hypersensitivity IgA Vasculitis Immune Complex Diseases Immune System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Purpura Signs and Symptoms Skin Diseases Skin Diseases, Vascular Skin Manifestations Skin and Connective Tissue Diseases Vascular Diseases Vasculitis

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sirui Yang

Changchun, Changchun/JiLin, 130021, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

IL-2

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

The First Hospital of Jilin University

Other

Registry information

Acronym: HSP

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 14, 2020
Registry last updated
Aug 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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