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

J

Jilin University

Status

Completed

Conditions

Purpura, Schoenlein-Henoch

Treatments

Drug: IL-2

Study type

Interventional

Funder types

Other

Identifiers

NCT04387942
20K012-001

Details and patient eligibility

About

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

Full 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.

Enrollment

59 patients

Sex

All

Ages

Under 17 years old

Volunteers

Accepts 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.

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

59 participants in 2 patient groups

Recombinant Human Interleukin-2
Experimental group
Description:
patients were treated with IL-2.
Treatment:
Drug: IL-2
Traditional therapy
No Intervention group
Description:
patients were treated with dipyridamole and/or glucocorticoid,immunosuppressor.

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems