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Clinical Trials in China / NCT06971913
Starting soon Phase 2

Efficacy and Safety of Low-dose IL-2 in SLE Patients With CMV Viremia

NCT06971913 · tracked via the Priya Life Science China tracker
Sponsor
Peking University People's Hospital
Phase
Phase 2
Started
2025-05-20
Last updated
2025-05-14

Condition(s) studied

SLE (Systemic Lupus)CMV

Investigational drug(s) / intervention(s)

Interleukin-2 (IL-2) →Ganciclovir (GCV)

Interleukin-2 (IL-2): Low-dose IL-2 at 1MIU will be administered subcutaneously every other day from baseline to CMV negativity.

Ganciclovir (GCV): Ganciclovir injection will be administrated intravenously at a dose of 5mg/kg per day.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * 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 Criteria: * 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.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Peking University People's Hospital Beijing Bejing

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Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06971913 on ClinicalTrials.gov ↗ ← All trials in China