在中国真实世界环境中评估索磷布韦治疗方案用于慢性丙型肝炎病毒(HCV) 感染患者的安全性和有效性的批准上市后研究
[Translation] Post-approval study to evaluate the safety and efficacy of sofosbuvir regimen in patients with chronic hepatitis C virus (HCV) infection in a Chinese real-world setting
本研究的主要目标是: 描述在常规临床实践中使用含有索磷布韦方案治疗慢性 HCV 感染患者的不良事件发生率 本研究的次要目标是: 描述停止治疗后约 12 周的持续病毒学应答率,其定义为停止治疗后约12 周时HCV RNA < LLOQ 患者的比例
[Translation] The primary objectives of this study were: To describe the incidence of adverse events in patients with chronic HCV infection treated with a sofosbuvir-containing regimen in routine clinical practice The secondary objectives of this study were: To describe the sustained virological response approximately 12 weeks after discontinuation of treatment rate, defined as the proportion of patients with HCV RNA < LLOQ at approximately 12 weeks after stopping treatment
Sofosbuvir/GS-5816开放标签单次给药和多次给药在健康中国受试者中的安全性、耐受性和药代动力学研究
[Translation] The safety, tolerability and pharmacokinetics of Sofosbuvir/GS-5816 open-label single-dose and multiple-dose studies in healthy Chinese subjects
评估健康中国受试者中 Sofosbuvir/GS-5816 固定剂量复合制剂 (FDC) 片剂单次给药和多次给药的药代动力学。评估健康中国受试者中 SOF/GS-5816 FDC 片剂单次给药和多次给药的安全性和耐受性。
[Translation] To evaluate the pharmacokinetics of single- and multiple-dose Sofosbuvir/GS-5816 fixed-dose combination (FDC) tablets in healthy Chinese subjects. To evaluate the safety and tolerability of SOF/GS-5816 FDC tablets in single and multiple doses in healthy Chinese subjects.
一项旨在调查 12 周 Sofosbuvir/GS-5816治疗对慢性 HCV 感染受试者的疗效和安全性的 III 期多中心开放标签研究
[Translation] A Phase III, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of 12-Week Sofosbuvir/GS-5816 Treatment in Subjects with Chronic HCV Infection
针对慢性 HCV 感染受试者评估 12 周 Sofosbuvir (SOF)/ GS-5816治疗的疗效,通过停止治疗后 12 周实现的持续病毒学应答 (SVR12) 的受试者比例进行衡量;评估 12 周 SOF/GS-5816 治疗的安全性和耐受性
[Translation] Efficacy of 12-week Sofosbuvir (SOF)/GS-5816 treatment was assessed in chronic HCV-infected subjects, as measured by the proportion of subjects who achieved sustained virological response (SVR12) 12 weeks after treatment discontinuation; 12-week SOF/GS-5816 was assessed Safety and Tolerability of GS-5816 Treatment
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