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
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 who responded to prior treatment with oral dexamethasone 40 mg/day for 4 days, defined as meeting all three 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; and ③ no active bleeding. Between Week 2 and Week 12, any abnormal PLT result meeting any of the following criteria must be confirmed by repeat testing at Qilu Hospital within 24-48 hours: ① PLT \<30×10⁹/L; ② \<2-fold increase from baseline; or ③ active bleeding.
• Women of childbearing potential must use an effective method of contraception during the screening period, throughout the entire trial, and for 90 days following the last dose of study medication.