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NCT05694130
Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS
Conditions: Sjogren Syndrome With Other Organ Involvement
Sex: All
Ages: 18 Years – 70 Years
Phase: PHASE2, PHASE3
Enrollment: 110
Sponsor: Peking Union Medical College Hospital
Summary
This 12-week randomized, open-label study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for Sjogren's syndrome patients with severe thrombocytopenia.
Eligibility Criteria
Inclusion Criteria:Diagnosis of Sjogren's syndrome according to the 2002 revised American-European Consensus Group (AECG) criteria.Baseline platelet counts less than 30×109/L.Exclusion Criteria:Concomitant other systemic autoimmune diseases.Other severe complications of Sjogren's syndrome.Abnormal laboratory tests such as: white blood cell count <2.5x10^9/L, hemoglobin <80 g/L, AST/ALT >1.5 ULN, serum creatine > 1.5 mg/dL.Received glucocorticoids, immunosuppressants, or biological agents within 3 months.Active acute or chronic infections.History of malignancy.Pregnancy or breastfeeding.
Source: ClinicalTrials.gov (NCT05694130). StuddyBuddy aggregates publicly available trial information.