[Translation] A randomized, double-blind, double-dummy, parallel-controlled, multicenter, Phase II/III clinical study to evaluate the efficacy and safety of OB756 tablets versus hydroxyurea tablets in the treatment of patients with intermediate- and high-risk myelofibrosis (BEWELL-301 study)
主要目的:
1.评价OB756片治疗中高危骨髓纤维化(MF)受试者的脾脏体积缩小有效率。
次要目的:
1.评价OB756片治疗中高危骨髓纤维化(MF)受试者的客观有效率、脾响应、MF相关症状改善等;
2.评价OB756片治疗中高危骨髓纤维化(MF)受试者的安全性。
[Translation] Main purpose:
1. To evaluate the effectiveness of OB756 tablets in reducing spleen volume in subjects with intermediate- and high-risk myelofibrosis (MF).
Secondary purpose:
1. To evaluate the objective effectiveness rate, spleen response, and improvement of MF-related symptoms in subjects with intermediate- and high-risk myelofibrosis (MF) treated with OB756 tablets;
2. To evaluate the safety of OB756 tablets in treating subjects with intermediate- and high-risk myelofibrosis (MF).