一项开放标签、多中心研究,以评估 ABT 493/ABT-530 联合索磷布韦和利巴韦林治疗在艾伯维慢性丙肝(HCV)临床研究(MAGELLAN-3)中出现病毒学失败的 HCV感染受试者的有效性和安全性
[Translation] An open-label, multicenter study to evaluate the efficacy and safety of ABT 493/ABT-530 in combination with sofosbuvir and ribavirin in HCV-infected subjects experiencing virologic failure in AbbVie's chronic hepatitis C (HCV) clinical study (MAGELLAN-3)
本研究的主要目的是通过评价 ABT-493/ABT-530 联合 SOF 和 RBV 治疗方案给药后,每个治疗组中获得治疗结束后 12 周持续性病毒学应答(SVR12)的受试者百分比,以此评估有效性以及该方案在既往在艾伯维 HCV 临床研究(指艾伯维 HCV 母研究)中接受 HCV 治疗失败的慢性HCV GT1-6 感染的成人或青少年中的安全性。
次要目的是评估出现 HCV 治疗中病毒学失败的受试者百分比和出现HCV 病毒学复发的受试者百分比。
[Translation] The primary objective of this study is to evaluate the efficacy of ABT-493/ABT-530 in combination with SOF and RBV by evaluating the percentage of subjects in each treatment group who achieve a sustained virologic response 12 weeks after the end of treatment (SVR12), as well as the safety of this regimen in adults or adolescents with chronic HCV GT1-6 infection who have previously failed HCV treatment in AbbVie HCV clinical studies (referred to as the AbbVie HCV Parent Study).
The secondary objectives are to evaluate the percentage of subjects who experience virologic failure during HCV treatment and the percentage of subjects who experience HCV virologic relapse.
一项开放、随机、在中国健康男性和女性受试者中进行的单次和多次服用ABT-335后非诺贝特酸的药代动力学研究
[Translation] An open-label, randomized, pharmacokinetic study of fenofibric acid after single and multiple doses of ABT-335 in healthy Chinese male and female subjects
主要目的:确定健康中国男性和女性受试者单次和多次服用ABT-335后非诺贝特酸的药代动力学特征。 安全性目的:评价健康中国男性和女性受试者单次和多次服用ABT-335 45 mg和135 mg胶囊制剂后的安全性和耐受性。
[Translation] Primary objective: To determine the pharmacokinetic profile of fenofibric acid after single and multiple doses of ABT-335 in healthy Chinese male and female subjects. Safety objective: To evaluate the safety and tolerability of ABT-335 45 mg and 135 mg capsule formulations after single and multiple doses in healthy Chinese male and female subjects.
一项在健康中国受试者中评价ABT-493/ABT-530片剂药代动力学、安全性和耐受性的1期、开放、多剂量研究
[Translation] A Phase 1, open-label, multiple-dose study to evaluate the pharmacokinetics, safety, and tolerability of ABT-493/ABT-530 tablets in healthy Chinese subjects
评价健康中国成年受试者在非空腹条件下重复口服ABT-493/ABT-530时的药代动力学、安全性和耐受性
[Translation] To evaluate the pharmacokinetics, safety and tolerability of ABT-493/ABT-530 after repeated oral administration under non-fasting conditions in healthy Chinese adult subjects
100 Clinical Results associated with Fournier Laboratories Ireland Ltd.
0 Patents (Medical) associated with Fournier Laboratories Ireland Ltd.
100 Deals associated with Fournier Laboratories Ireland Ltd.
100 Translational Medicine associated with Fournier Laboratories Ireland Ltd.