Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS

• Status: Not yet recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Prednisolone; Tacrolimus

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.