Change of Renal Function and Bone Mineral Density Marker in Chronic Hepatitis B Patients Switching from TDF to TAF Vs. Maintaining TDF
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 575
- 试验地点
- 1
- 主要终点
- Antiviral response of TAF
研究概览
简要总结
In Chronic hepatitis B (CHB) patients receiving long-term sequential Neucleos(t)ides(NAs), majority of these CHB patients experienced drug resistance and switched to Tenofovir disoproxil fumaratate(TDF). However, some of patients on long term TDF experienced impairment of renal function and bone mineral density. After Tenofovir alafenamide(TAF) was in clinical practice, these group of patients got an clinical option to switch from TDF to TAF. The investigators designed a prospective cohort study to evaluate the real life effectiveness and safety in participants with chronic HBV infection switch from TDF to TAF vs. maintaining on TDF.
详细描述
Tenofovir disoproxil fumarate(TDF) have been associated with renal toxicity and reduced bone mineral density. Tenofovir alafenamide(TAF) is a novel tenofovir prodrug that reduces tenofovir plasma concentrations by 90%, thereby decreasing off-target side-effects. The investigators aimed to assess whether efficacy, safety, and tolerability were non-inferior in participants switched to TAF versus in those remaining on TDF. This is a prospective clinical study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic hepatitis B,
- •Antiviral experienced,
- •Currently on long term TDF anti-HBV treatment,
- •HBV DNA < 6 log IU/ml (LLOD)
- •Able to sign the consent form of anticipating in the study
排除标准
- •Co-infected with HCV, HIV or other viral hepatitis,
- •Diagnosis of HCC
研究组 & 干预措施
TDF switch to TAF
Tenofovir Disoproxil Fumarate(TDF) 300mg daily switch to Tenofovir Alafenamide(TAF) 25mg daily
干预措施: Tenofovir alafenamide(TAF) (Drug)
Maintaining on TDF
Maintaining on Tenofovir Disoproxil Fumarate(TDF) 300mg daily
干预措施: Tenofovir disoproxil fumarate(TDF) (Drug)
结局指标
主要结局
Antiviral response of TAF
时间窗: 60 months
Anti-HBV effectiveness of TAF compared with TDF in treatment experienced CHB patients
次要结局
- Improvement of renal function and bone mineral density in CHB patients switching to TAF(60 months)
研究者
George Lau
Humanity & Healthy Medical Group President
Humanity and Health Research Centre