Status:
COMPLETED
The Therapeutic Value and Mechanism of Recombinant Human Interleukin-2 on Children With Rheumatic Diseases
Lead Sponsor:
The First Hospital of Jilin University
Conditions:
Systemic Lupus Erythematosus
Eligibility:
All Genders
Up to 17 years
Phase:
NA
Brief Summary
The study aims to explore the therapeutic value and mechanism of Interleukin-2 on children with rheumatic diseases (Systemic Lupus Erythematosus, Primary Sjögren Syndrome, Juvenile Idiopathic Arthriti...
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 ...
Eligibility Criteria
Inclusion
- age \<18 years old
- meet the diagnostic criteria of disease classification
- HIV negative;Negative for Hepatitis B Virus and Hepatitis C Virus.
Exclusion
- 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;Rituximab, infliximab or other biological agents were used
- mental disorders or any other chronic illness or substance abuse may interfere with the ability to comply with agreements or provide information
- Inability to comply with IL-2 treatment regimen.
Key Trial Info
Start Date :
August 15 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 30 2022
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04397107
Start Date
August 15 2020
End Date
June 30 2022
Last Update
August 18 2022
Active Locations (1)
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1
Sirui Yang
Changchun, Changchun/Jilin, China, 130000