This is a randomized controlled study of high-dose Dexamethasone combined with Orelabrutinib versus high-dose Dexamethasone combined with placebo in adult patients with newly diagnosed Primary Immune Thrombocytopenia.
Subjects must thoroughly understand the nature, significance, potential benefits, possible inconveniences, and potential risks of the trial prior to enrollment. They must understand the study procedures and voluntarily sign the informed consent form.
Male or female subjects aged 18-80 years (inclusive).
Body weight ≥35 kg at screening.
Adult patients with newly diagnosed, untreated primary ITP, with platelet count (PLT) <30×10⁹/L and no active bleeding in vital organs.
Subjects with severe ITP at screening (e.g., life-threatening thrombocytopenia, major bleeding events, or requiring urgent treatment including intravenous immunoglobulin, high-dose glucocorticoids, or plasma exchange), whom the investigator anticipates will require rescue treatment within 2 weeks after enrollment.
Subjects with autoimmune systemic diseases other than ITP, unless the investigator determines that such conditions will not affect the evaluation of study outcomes.
Subjects who failed to respond to prior treatment with oral dexamethasone 40 mg/day for 4 days, defined as meeting any of the following criteria on any day between Day 5 and Day 7 post-treatment: ① PLT <30×10⁹/L; ② <2-fold increase from baseline; or ③ active bleeding.
History of intracranial hemorrhage within 6 months prior to screening.
Shandong University
Lead sponsor
Qilu Hospital of Shandong University
Sponsor institution