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临床试验/NCT05423834
NCT05423834进行中(未招募)不适用

Chronic Kidney Disease Progression in Chronic Hepatitis B Patients on Tenofovir Alafenamide (TAF) Versus Entecavir

Chinese University of Hong Kong1 个研究点 分布在 1 个国家目标入组 1,800 人开始时间: 2022年9月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
1,800
试验地点
1
主要终点
CKD at 12 months

研究概览

简要总结

Tenofovir alafenamide (TAF), a novel prodrug of tenofovir (TFV), has been approved for the treatment of chronic hepatitis B virus (HBV) infection. TAF has been shown to be a potent inhibitor of HBV replication at a low dose, with high intracellular concentration and more than 90% lower systemic TFV concentration than tenofovir disoproxil fumarate (TDF). TAF has been approved in the clinical practice guidelines in the west. Since its availability in Asia in 2017, there have been evolving data concerning its positive impact on renal safety as shown in registration trials.

The primary objective of this study is to compare the risk of chronic kidney disease (CKD) progression in chronic hepatitis B patients on TAF versus ETV in a territory-wide cohort in Hong Kong.

详细描述

Antiviral therapy with nucleos(t)ide analogues (NAs) has revolutionized the management of chronic hepatitis B (CHB) in the last two decades.1 Entecavir (ETV), a nucleoside analogue, is one of the first-line NAs recommended by all international treatment guidelines.2-4 As hepatitis B surface antigen (HBsAg) seroclearance rarely occurs, most patients require long-term, if not life-long, NA therapy. Hence, the safety of NAs requires careful scrutiny. In clinical trials, nephrotoxicity may occur in a small proportion of patients receiving nucleotide analogues. We previously demonstrated that tenofovir disoproxil fumarate (TDF) was associated with mild renal impairment in a minority of patients; those treated with entecavir (ETV) had a similar risk compared to untreated patients.5

Tenofovir alafenamide (TAF), a novel prodrug of tenofovir (TFV), has been approved for the treatment of chronic hepatitis B virus (HBV) infection. TAF has been shown to be a potent inhibitor of HBV replication at a low dose, with high intracellular concentration and more than 90% lower systemic TFV concentration than tenofovir disoproxil fumarate (TDF). TAF has been approved in the clinical practice guidelines in the west. Since its availability in Asia in 2017, there have been evolving data concerning its positive impact on renal safety as shown in registration trials.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Positive hepatitis B surface antigen (HBsAg) or documented history of CHB for 6 months or more; AND
  • On TAF 25 mg daily as antiviral treatment for CHB (cases); OR
  • On ETV 0.5 to 1.0 mg daily as antiviral treatment for CHB (controls)

排除标准

  • Previous NA treatment prior to TAF or ETV
  • Positive antibody against hepatitis C, D, or human immunodeficiency virus (anti-HCV, anti-HDV, or anti-HIV)
  • Evidence of other autoimmune or metabolic liver diseases (except non-alcoholic fatty liver disease).
  • Moribund state including advanced/pre-terminal liver cancer or other non-hepatic cancers
  • Non-hepatic cancer undergoing chemotherapy within last 6 months

研究组 & 干预措施

TAF-treated Chronic hepatitis B patients

Chronic hepatitis B patients that treated with Tenofovir alafenamide

干预措施: Tenofovir alafenamide (Drug)

ETV-treated Chronic hepatitis B patients

Chronic hepatitis B patients that treated with Entecavir

干预措施: Entecavir (Drug)

结局指标

主要结局

CKD at 12 months

时间窗: 12 months

To evaluate chronic kidney disease (CKD) progression at 12 months. The CKD progression is defined as an increase in CKD stage for at least 1 stage for at least 3 consecutive months during follow-up.

次要结局

  • Change in eGFR(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Grace Lai Hung Wong

Professor

Chinese University of Hong Kong

研究点 (1)

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