跳至主要内容
临床试验/NCT02957994
NCT02957994Unknown4 期

Analysis of Proximal Renal Tubular Function of "Real World" Chronic Hepatitis B (CHB) Patients Who Are Suppressed on TDF and Switched to TAF

Asian Pacific Liver Center at Coalition of Inclusive Medicine0 个研究点目标入组 82 人开始时间: 2016年12月22日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
82
主要终点
measure renal function after switch to TAF

研究概览

简要总结

To evaluate various markers of renal function and bone density after the switch to Tenofovir alafenamide fumarate (TAF) in chronic hepatitis B patients who are currently treated with Tenofovir disoproxil fumarate (TDF) .

详细描述

The investigators have previously reported the prevalence of abnormal renal tubular reabsorption of phosphate among CHB patients treated with more than 18 months of TDF to be 48%. Renal tubular dysfunction associated with TDF may be reversible when TDF is discontinued 4. Recently, TAF 25 mg daily was shown to have comparable efficacy to TDF 300 mg with respect to viral suppression in both HBeAg positive and HBeAg negative CHB patients (studies 110 and 108) at 48 weeks of therapy. As speculated, the systemic exposure to tenofovir was significantly less in patients exposed to TAF compared to those on TDF with strikingly less effects noted in a variety of renal and bone parameters for individuals receiving TAF. Notably, however, the question remains to what if any improvements may be seen in CHB patients switched from TDF to TAF.

The investigators propose a prospective open label study to evaluate various markers of renal function and bone density in 80 CHB patients who are currently treated with TDF who are switched to TAF.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients with chronic hepatitis B (who are either HBeAg reactive or non-reactive)
  • Treated with TDF with unquantifiable Hepatitis B Virus (HBV) DNA by a sensitive Polymerase chain reaction (PCR) assay for a minimum of 6 months
  • No prior nucleos(t)ide exposure prior to treatment with TDF
  • Treatment with TDF for a minimum of 12 months

排除标准

  • HIV Infection

研究组 & 干预措施

TAF Arm

Experimental

Tenofovir alafenamide fumarate 25mg, 1 tablet once daily for 24 weeks

干预措施: Tenofovir alafenamide fumarate (Drug)

结局指标

主要结局

measure renal function after switch to TAF

时间窗: one year

Kidney function will be measured by blood and urine to compare abnormal results before and after switching to TAF.

measure bone density after switch to TAF

时间窗: one year

Bone density will also be measured to compare T score and Z score before and after switching to TAF

次要结局

未报告次要终点

研究者

发起方
Asian Pacific Liver Center at Coalition of Inclusive Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ho Bae

Medical Director

Asian Pacific Liver Center at Coalition of Inclusive Medicine

相似试验

TAF Switch Study in Hepatitis B Monoinfection | 临床试验