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Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies

Immune Thrombocytopenia Clinical Trial

Official title:
Efficacy and Safety of Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies Fail to Eltrombopag or Herombopag Treatment: a Single-center, Prospective, One-arm Clinical Trial

Clinical Trial Summary

This prospective, open-label, single-center, one-arm clinical trial aims at evaluating the efficacy and safety of avatrombopag in Chinese adult Immune Thrombocytopenia (ITP) patients with autoantibodies fail (due to intolerance or resistance) to eltrombopag or herombopag treatment.

Clinical Trial Description

This prospective, open-label, single-center, one-arm clinical trial aims at evaluating the efficacy and safety of avatrombopag in Chinese adult ITP patients with autoantibodies fail (due to intolerance or resistance) to eltrombopag or herombopag 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. Fifty-two eligible subjects will be enrolled in this study. The dose will be adjusted according to the platelet count during the period from week 1 to week 12. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04993885
Study type Interventional
Source Institute of Hematology & Blood Diseases Hospital, China
Contact Rongfeng Fu, M.D.
Phone +862223909009
Email furongfeng@ihcams.ac.cn
Status Recruiting
Phase Phase 2
Start date September 1, 2021
Completion date September 30, 2024
View Details
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