This study is a prospective, single-center, single-arm, open-label, exploratory study that includes adult patients with persistent or chronic ITP who have received at least one prior line of therapy. The study was approved by the Ethics Committee of the Chinese Academy of Medical Sciences and Peking Union Medical College (IIT2023078-EC-1), and all patients provided written informed consent. The trial was registered with chictr.org.cn (NCT06287567).
The main inclusion criteria are:
- Age 18 years or older;
- Diagnosed with primary persistent or chronic ITP for ≥3 months prior to screening, excluding other secondary thrombocytopenias such as MDS, AA, and SLE;
- At least one prior treatment failure for ITP, with or without splenectomy;
- Prior rescue treatments for ITP (including but not limited to corticosteroids, platelet transfusions, immunoglobulins, immunomodulators, and cyclophosphamide) must have been completed at least 1 week before dosing or deemed ineffective within 1 week;
- Mean PLT count <3010^9/L on two occasions during the screening period; if receiving glucocorticoid therapy, mean PLT count <5010^9/L on two occasions during the screening period, with intervals of 2-14 days between measurements;
- Patients may be receiving stable doses of immunosuppressants such as cyclosporine, mycophenolate mofetil, azathioprine, or danazol (stable for ≥4 weeks prior to enrollment) or glucocorticoids (for ≥2 weeks prior to dosing).
The main exclusion criteria are: A history of clinically significant hemorrhagic coagulation disorders; Use of rhTPO or TPO-RA within 4 weeks before enrollment or prior use of rhTPO or TPO-RA with no response; A history of clinically significant cardiovascular or thromboembolic disease within 26 weeks before screening; Splenectomy within 4 weeks before screening.
