Phase II Study of Orelabrutinib in Combination With Romiplostim N01 in Patients With Primary Immune Thrombocytopenia (ITP) Who Have Received At Least One Prior Line of Therapy

Exclusion Criteria

• •1. Subjects suffer from severe ITP at screening;
• •2. Subjects have other diseases which mention in protocol;
• •3. Subjects develop intracranial hemorrhage within 6 months prior to screening;
• •4. Active and uncontrollable infection;
• •6\. Subjects have a history of coagulopathy other than ITP; 7. Subjects with a history of malignancies; 8. History of major organ transplantation or hematopoietic stem cell/bone marrow transplantation; 9. Subjects with a known history of hypersensitivity to the investigational drug as described in the Protocol, or any ingredients; 10. Subjects with a Medication history and surgical history which mention in protocol; 11. Subjects do not meet the criterion of the laboratory test in protocol.
• •Withdrawal Criteria:
• •1. If, after 4 consecutive weeks of Romiplostim N01 administration at the maximum dose (10 µg/kg once weekly), the platelet count remains \<50×10⁹/L and the investigator judges the investigational product to be ineffective for the subject, such that continued use is not in the subject's best interest；
• •2. Subjects who are unable to successfully undergo treatment tapering or discontinuation；
• •3. Subjects who, during the treatment period, require rescue therapy based on clinical assessment；
• •4. Subjects who withdraw their informed consent.
• •5. Occurrence of pregnancy during the trial period
• •6. Poor subject compliance or a significant protocol violation；
• •7. Loss to follow-up；
• •8. The investigator decides that withdrawal is necessary for the subject's safety；
• •9. Presence of other conditions, as determined by the investigator, that may affect the study results or lead to premature termination of the study；
• •10. Study completion or early termination of the entire study.