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Actively Recruiting

Phase 2
Age: 18Years +
All Genders
ID04993885

Evaluating Avatrombopag for Adults with Immune Thrombocytopenia and Autoantibody-Related Treatment Failure

Led by Institute of Hematology & Blood Diseases Hospital, China · Updated on 2025-02-24

52

Participants Needed

1

Research Sites

60 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the safety and effectiveness of avatrombopag in adult Chinese patients with Immune Thrombocytopenia ITP who have autoantibodies and have not responded well or cannot tolerate treatments with eltrombopag or herombopag. This is a phase 2, open-label, single-center, one-arm clinical trial focusing on patients with various forms of ITP, including those linked to connective tissue diseases and Evans syndrome variants. Participants will receive avatrombopag starting at 40 mg once daily. Platelet counts will be monitored weekly during the first four weeks and then every two weeks up to week 12. Doses may be adjusted between 20 mg and 40 mg daily to keep platelet levels within a target range. If platelet counts remain low after four weeks at the initial dose, treatment will be discontinued. Throughout the 12-week treatment period, researchers will assess platelet response, duration, and time to response. Additional measurements include bleeding scores, disease activity in systemic lupus erythematosus, symptom improvements, immune function, glucocorticoid discontinuation, fatigue, and patient-reported outcomes. Safety and efficacy will be closely monitored during this time to understand avatrombopags impact on these patients.

CONDITIONS

Brief Title

Avatrombopag in the Treatment of Adult Immune Thrombocytopenia With Autoantibodies

Research Team

R

Rongfeng Fu, M.D.

L

Lei Zhang, M.D.

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