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Clinical Trial Summary

To evaluate the efficacy and safety of bortezomib in the first-line treatment of patients with acquired TTP,we design this prospective, multi-center, single-arm interventional study.All enrolled TTP patients were given bortezomib 1.3 mg/m2 intravenous injection d1, 4, 8, on the basis of standard single membrane plasma exchange (2L/d) and hormone therapy (1mg/kg prednisone or equivalent methylprednisolone). 11 (4 doses in total). Bortezomib should be administered immediately after each plasma exchange, and the interval between the next plasma exchange is> 24h. Plasma exchange continued until the patient's platelet count was >100×109/L for 2 consecutive days, and then changed to once every other day for a total of two times and then stopped.


Clinical Trial Description

To evaluate the efficacy and safety of bortezomib in the first-line treatment of patients with acquired TTP,we design this prospective, multi-center, single-arm interventional study.All enrolled TTP patients were given bortezomib 1.3 mg/m2 intravenous injection d1, 4, 8, on the basis of standard single membrane plasma exchange (2L/d) and hormone therapy (1mg/kg prednisone or equivalent methylprednisolone). 11 (4 doses in total). Bortezomib should be administered immediately after each plasma exchange, and the interval between the next plasma exchange is> 24h. Plasma exchange continued until the patient's platelet count was >100×109/L for 2 consecutive days, and then changed to once every other day for a total of two times and then stopped. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05135442
Study type Interventional
Source Peking Union Medical College Hospital
Contact jing yang
Phone 1069159146
Email yangbujing@126.com
Status Not yet recruiting
Phase Phase 4
Start date December 1, 2021
Completion date November 30, 2025

See also
  Status Clinical Trial Phase
Not yet recruiting NCT04720261 - Efficacy of a Personalized Caplacizumab Regimen Based on ADAMTS13 Activity Monitoring in Adult aTTP Phase 2
Not yet recruiting NCT05262881 - A Retrospective, Observational Study on the Response to Caplacizumab Treatment in aTTP Patients: the Italian Experience (ROSCAPLI)