NCT02791386已完成不适用
Rescue Treatment Pattern, Drug Resistance Recurrence, and Direct Medical Costs Associated With Chinese Patients With Chronic Hepatitis B and Drug Resistance to Nucleot(s)Ide Analogue Monotherapy: A Retrospective Cohort Study
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 383 人开始时间: 2016年11月22日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 383
- 试验地点
- 1
- 主要终点
- Rescue treatments effect on direct medical costs associated with CHB patients who were followed for drug resistance to NA therapy at the tertiary liver clinic of SXH
研究概览
简要总结
The purpose of this study is to describe current rescue treatment pattern for nucleot(s)ide analogue (NA) resistance and assess the real-world treatment outcomes and health resources utilization of rescue treatments for drug resistance in a clinical cohort of Chinese patients with chronic hepatitis B (CHB).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •CHB patient with drug resistance confirmed by hepatitis B virus (HBV) gene mutation and virological breakthrough
- •Patient receiving rescue treatments for drug resistance to previous NA therapy for CHB
- •Patient who was regularly followed at least every 6 months for drug resistance at the tertiary liver clinic of SXH
排除标准
- •Patient with a diagnosis of hepatocellular carcinoma, decompensated cirrhosis, and/or liver transplantation prior to the development of drug resistance to NA therapy for CHB
- •Patient with co-infection with hepatitis C virus, hepatitis D virus, and/or human immunodeficiency virus
- •Patient with life expectancy less than 6 months after the date of the first laboratory test indicating drug resistance
- •Other protocol defined inclusion/exclusion criteria could apply
结局指标
主要结局
Rescue treatments effect on direct medical costs associated with CHB patients who were followed for drug resistance to NA therapy at the tertiary liver clinic of SXH
时间窗: Retrospectively collected from March 31, 2008 to August 15, 2016
Direct medical costs associated with CHB patients who were regularly followed for drug resistance to NA therapy at the tertiary liver clinic of the Second Xiangya Hospital (SXH) in Changsha, Hunan, China
时间窗: Retrospectively collected from March 31, 2008 to August 15, 2016
次要结局
- Biochemical response recurrence associated with rescue treatments for drug resistance to NA therapy in CHB patients who were followed at the tertiary liver clinic of SXH(Retrospectively collected from March 31, 2008 to August 15, 2016)
- Rescue treatment patterns associated with CHB patients who were regularly followed for their drug resistance to NA therapy at the tertiary liver clinic of SXH(Retrospectively collected from March 31, 2008 to August 15, 2016)
- Rescue treatments effect on liver-related complications in CHB patients who were followed up for drug resistance to NA therapy at the tertiary liver clinic of SXH(Retrospectively collected from March 31, 2008 to August 15, 2016)
- Rescue treatments effect on mortality in CHB patients who were followed up for drug resistance to NA therapy at the tertiary liver clinic of SXH(Retrospectively collected from March 31, 2008 to August 15, 2016)
- Virological response recurrence associated with rescue treatments for drug resistance to NA therapy in CHB patients who were followed at the tertiary liver clinic of SXH(Retrospectively collected from March 31, 2008 to August 15, 2016)
- Drug resistance recurrence associated with rescue treatments for drug resistance to NA therapy in CHB patients who were followed at the tertiary liver clinic of SXH(Retrospectively collected from March 31, 2008 to August 15, 2016)
研究者
研究点 (1)
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