[Translation] An open-label, single-arm, post-registration pragmatic clinical trial of the safety and efficacy of sedatives in Chinese hemophilia A subjects under conventional treatment settings
在中国常规治疗环境下,评估甲型血友病受试者接受任捷后出现的医学重要事件(FVIII抑制物形成)的情况。
次要目的:
在中国普通医疗单位,评估甲型血友病受试者接受任捷的总体安全性(包括AE和SAE发生率)和任捷的按需治疗和手术预防治疗的有效性。
探索性目的:
在接受按需治疗的儿童受试者中评估患者报告结局。
[Translation] To evaluate the occurrence of medically important events (FVIII inhibitor formation) in hemophilia A subjects receiving Renjie in the routine treatment setting in China.
Secondary objective:
To evaluate the overall safety (including AE and SAE incidence) of Renjie in hemophilia A subjects receiving Renjie in general medical institutions in China and the effectiveness of Renjie for on-demand treatment and surgical prophylaxis.
Exploratory objective:
To evaluate patient-reported outcomes in pediatric subjects receiving on-demand treatment.