計劃書編號GS-TW-367-5936
2022-01-01 - 2024-09-30
Phase IV
ICD-10B18.2
慢性病毒性C型肝炎
ICD-9070.54
慢性C型肝炎,未提及肝昏迷
A multicenter, observational Post Authorization Study (PAS) to evaluate the safety and effectiveness of Vosevi® in the treatment of patients with chronic hepatitis C virus (HCV) in Taiwan
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試驗申請者
香港商吉立亞醫藥有限公司台灣分公司
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試驗委託 / 贊助單位名稱
香港商吉立亞醫藥有限公司台灣分公司
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臨床試驗規模
台灣多中心
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更新日期
2025/08/20
試驗主持人及試驗醫院
適應症
未併有肝硬化或併有代償性肝硬化(Child-Pugh A級)的成人慢性C型肝炎病毒(HCV)感染症,並且符合以下任一條件:
• 基因型1、2、3、4、5或6,且曾經接受含NS5A抑制劑之HCV療程。
• 基因型1a或3,且曾經接受含sofosbuvir但無NS5A抑制劑之HCV療程。
說明: 對於基因型1b、2、4、5或6,且曾經接受含sofosbuvir但無NS5A抑制劑之HCV療程的成人病人,VOSEVI的效益並未顯示優於sofosbuvir/velpatasvir。
試驗目的
The purpose of this study is to evaluate the safety and effectiveness
of Vosevi under real world settings in patients with chronic HCV.
藥品名稱
Vosevi Film-Coated Tablets
主成份
sofosbuvir
velpatasvir
voxilaprevir
velpatasvir
voxilaprevir
劑型
膜衣錠
膜衣錠
膜衣錠
膜衣錠
膜衣錠
劑量
400
100
100
100
100
評估指標
The primary objective of this study is to assess the overall safety profile of Vosevi treatment in patients with chronic HCV who have previously failed on one or more HCV regimen. Focus will be given to special health outcomes of interest (HOIs) such as hyperbilirubinemia and drug-induced liver injury (DILI).
The secondary objective of this study is to describe the effectiveness of Vosevi as measured by the sustained virological response (SVR) rate after approximately 12 weeks (SVR12) from completion or discontinuation of treatment, where SVR is defined as HCV RNA below the lower limit of quantification. In addition, this study will also measure SVR rate after approximately 24 weeks for the high risk population, defined per Taiwan Association for the Study of the Liver (TASL) HCV guidelines of post-SVR monitoring and clinical practice.
The secondary objective of this study is to describe the effectiveness of Vosevi as measured by the sustained virological response (SVR) rate after approximately 12 weeks (SVR12) from completion or discontinuation of treatment, where SVR is defined as HCV RNA below the lower limit of quantification. In addition, this study will also measure SVR rate after approximately 24 weeks for the high risk population, defined per Taiwan Association for the Study of the Liver (TASL) HCV guidelines of post-SVR monitoring and clinical practice.
主要納入條件
Inclusion criteria:
Diagnosis of chronic HCV
Informed consent given by patient to be included in the TACR
Initiation of Vosevi treatment as captured in TACR
Without cirrhosis or with compensated cirrhosis (Child-Pugh A)
Age ≥ 20 years
Diagnosis of chronic HCV
Informed consent given by patient to be included in the TACR
Initiation of Vosevi treatment as captured in TACR
Without cirrhosis or with compensated cirrhosis (Child-Pugh A)
Age ≥ 20 years
試驗計畫預計收納受試者人數
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台灣人數
100 人
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全球人數
0 人