NCT05694130

Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in SS

Tacrolimus Plus Glucocorticoid for Severe Thrombocytopenia in Sjogren's Syndrome

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 110 (estimated)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This study evaluates the efficacy and safety of Tacrolimus combined with Glucocorticoid for the treatment of severe thrombocytopenia in Sjogren's syndrome patients.

Conditions

• Sjogren Syndrome With Other Organ Involvement

Interventions

Type	Name	Description
DRUG	Prednisolone	Oral prednisolone 1mg/kg daily for 4 weeks, then tapered to 7.5mg in 8 weeks.
DRUG	Tacrolimus	Oral Tacrolimus 1-2mg twice daily for 12 weeks.

Timeline

• Start date: 2023-02-01
• Primary completion: 2024-09-01
• Completion: 2024-12-01
• First posted: 2023-01-23
• Last updated: 2023-01-23