任捷在中国甲型血友病受试者中常规治疗环境下的安全性和有效性的开放性、单臂、注册后实用性临床试验
[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.
/ Active, not recruitingPhase 1 贝赋(诺那凝血素α)在中国男性乙型血友病受试者中的开放性、单剂量药代动力学研究
[Translation] An open-label, single-dose pharmacokinetic study of Befu (nonacoag alpha) in Chinese male subjects with hemophilia B
主要目的:确定中国男性乙型血友病受试者中贝赋的单剂量药代动力学特征
次要目的:评价中国男性乙型血友病受试者中贝赋的单剂量安全性和耐受性
[Translation] Primary objective: To determine the single-dose pharmacokinetic characteristics of Befu in Chinese male subjects with hemophilia B
Secondary objective: To evaluate the single-dose safety and tolerability of Befu in Chinese male subjects with hemophilia B
贝赋在中国乙型血友病受试者中常规治疗环境下的安全性和有效性的开放性、单臂、注册后实用性临床试验
[Translation] An open-label, single-arm, post-registration pragmatic clinical trial of the safety and efficacy of Beveta in Chinese hemophilia B subjects under conventional treatment settings
主要目的:
在中国常规医疗条件下,评估乙型血友病受试者接受贝赋后出现医学重要事件(产生FIX抑制物、过敏反应、血栓形成)的发生率和严重性。
次要目的:
在中国常规医疗条件下,评估乙型血友病受试者接受贝赋的总体安全性(包括AE和SAE发生率)和有效性。
探索性目的:
在儿童受试者中评估患者报告结局。
[Translation] Primary objective:
To evaluate the incidence and severity of medically important events (FIX inhibitor development, allergic reactions, thrombosis) in subjects with hemophilia B receiving bevacizumab under routine medical conditions in China.
Secondary objective:
To evaluate the overall safety (including AE and SAE incidence) and efficacy of bevacizumab in subjects with hemophilia B under routine medical conditions in China.
Exploratory objective:
To evaluate patient-reported outcomes in pediatric subjects.
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