Status:
NOT_YET_RECRUITING
Efficacy and Safety of Low-dose IL-2 in SLE Patients With CMV Viremia
Lead Sponsor:
Peking University People's Hospital
Conditions:
SLE (Systemic Lupus)
CMV
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
This clinical trial will assess the efficacy and safety of low-dose interleukin-2 (IL-2) treatment in systemic lupus erythematosus (SLE) complicated with cytomegalovirus (CMV) viremia.
Detailed Description
Systemic lupus erythematosus (SLE) is a chronic autoimmune syndrome affecting various organs, and infection is the leading cause of death in SLE. SLE patients are prone to opportunistic infections suc...
Eligibility Criteria
Inclusion
- Meet the American College of Rheumatology criteria for the diagnosis of SLE.
- The test for plasma CMV DNA viral load is positive.
- Age: 18 to 65 years, weight 45-80kg, male or female, gender ratio is not limited.
- Apply corticosteroid less than 1.0mg/kg/d.
- Written informed consent form.
Exclusion
- Inability to comply with IL-2 treatment regimen;
- Other active infections. (hepatitis B or C virus, Epstein-Barr virus, human immunodeficiency virus, Mycobacterium tuberculosis or pneumocystis carinii pneumonia)
- Any anti-CMV vaccine within 6 months;
- History of intravenous immunoglobulin (IVIG) or leflunomide within 6 months prior to randomization, and those who have undergone plasmapheresis;
- Active severe neuropsychiatric manifestations of SLE;
- Severe chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade III NYHA), hepatic insufficiency (transaminases\> 3N));
- Severe complications. (respiratory failure, heart failure or toxic shock)
- Complicated with other autoimmune diseases;
- Cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or Basocellular carcinoma);
- Pregnancy or lactation in females.
- Mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information;
- Participate in other clinical trial within 3 months.
Key Trial Info
Start Date :
May 20 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06971913
Start Date
May 20 2025
End Date
December 30 2025
Last Update
May 14 2025
Active Locations (1)
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1
Peking University People's Hospital
Beijing, Bejing, China, 100044