Primary Immune Thrombocytopenia Clinical Trial
Official title:
A Randomized, Multi-center, Adaptive Phase IIa/IIb Study to Evaluate the Efficacy and Safety of Orelabrutinib in Adult Patients With Persistent or Chronic Primary Immune Thrombocytopenia
The study is designed to be a randomized, open, multi-center, phase IIa/IIb seamless adaptive trial. Phase IIa: The study consists of a screening period, a core treatment period, an open label extension period, and a safety follow-up period Phase IIb: At present, a preliminary exploratory study (i.e., phase IIa study) will be conducted first. The design of the phase IIb study (including the selection of populations) will be clarified after a relatively clear understanding of the therapeutic effect, value, risks and benefits of the BTK inhibitor for ITP is obtained.
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