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ID05214391

Study of Zanubrutinib for Adults with Immune Thrombocytopenia Assessing Safety and Effectiveness in Treating Low Platelet Counts

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

30

Participants Needed

1

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

This research aims to evaluate the safety and effectiveness of zanubrutinib in treating immune thrombocytopenia ITP, a condition where the immune system causes low platelet counts leading to bleeding issues. ITP treatments currently have limited success, especially for patients who do not respond to standard therapies. Zanubrutinib is a newer drug that targets B cells involved in autoimmune diseases and has shown promise with fewer side effects compared to earlier treatments. In this study, 30 patients will take zanubrutinib starting at 80 mg once daily. If after 4 weeks the treatment is not effective and it is safe, the dose may be increased up to 160 mg twice daily. The treatment period lasts for 24 weeks. If severe side effects occur, the dose may be reduced or the patient may stop the treatment. This trial is designed to provide a new treatment option for adults with ITP who have not responded well to other therapies. Participants will have their platelet counts checked at 12 weeks to assess response and again at 24 weeks to evaluate sustained effects. The study also monitors bleeding severity, adverse events, and immune cell changes during treatment. Physical exams and lab tests will help ensure safety. The total participation time includes treatment and follow-up visits over 24 weeks to assess the drugs impact and safety profile.

CONDITIONS

Brief Title

A Prospective, One-arm and Open Clinical Study of Zanubrutinib in the Treatment of Immune Thrombocytopenia

Research Team

Y

Yunfei Chen

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