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Clinical Trial Summary

This prospective, open-label, nonrandomized, multicenter clinical trial aims at comparing the efficacy and safety of combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody vs. the best available therapy(BAT)in adult immune thrombocytopenia with autoantibodies failed (due to intolerance or resistance) to first-line treatment.


Clinical Trial Description

This is a prospective, open-label, nonrandomized, multicenter clinical trial aiming at comparing the efficacy and safety of combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody vs. the best available therapy(BAT)in adult immune thrombocytopenia (ITP) with autoantibodies failed (due to intolerance or resistance) to first-line treatment. The subjects include ITP secondary to connective tissue diseases (including but not limited to systemic lupus erythematosus, Sjogren's syndrome and rheumatoid arthritis), primary ITP with positive antinuclear antibody but not up to the diagnostic criteria of connective tissue diseases, primary Evans syndrome, Evans syndrome secondary to connective tissue diseases, and primary ITP with positive Coomb's test but not up to the diagnostic criteria of Evans syndrome. Adult ITP patients with autoantibodies (18-65 years) will be nonrandomly divided into the following two treatment groups: 1. combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody. 2. the best available therapy(BAT)other than combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody. The current treatment strategies and possible risks of combined use of TPO-RAs with low-dose anti-CD20 monoclonal antibody in the treatment of ITP with autoantibodies will be fully introduced to the patients by the researchers. Then the patients will be divided into one of the two groups according to the patients' will. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04915482
Study type Interventional
Source Institute of Hematology & Blood Diseases Hospital
Contact Rongfeng Fu, MD
Phone +862223909009
Email furongfeng@ihcams.ac.cn
Status Recruiting
Phase Phase 2/Phase 3
Start date June 6, 2021
Completion date February 28, 2024

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