Overview

Tacrolimus for Thrombocytopenia in SS

Status:
Not yet recruiting
Trial end date:
2024-03-01
Target enrollment:
0
Participant gender:
All
Summary
This 12-week randomized, open-label study evaluates the efficacy and safety of Tacrolimus for Sjogren's syndrome patients with thrombocytopenia.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Peking Union Medical College Hospital
Treatments:
Hydroxychloroquine
Tacrolimus
Criteria
Inclusion Criteria:

- Diagnosis of Sjogren's syndrome according to the 2002 revised American-European
Consensus Group (AECG) criteria.

- Baseline platelet counts within 30-80×109/L.

Exclusion Criteria:

- Concomitant other systemic autoimmune diseases.

- 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.