The Efficacy and Safety of TAF as a Prophylactic Antiviral Agent for HBsAg-positive Cancer Patients Receiving Chemotherapy
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 102
- 试验地点
- 5
- 主要终点
- The rate of HBV reactivation during TAF prophylaxis
研究概览
简要总结
Tenofovir alafenamide (TAF) has been approved to prevent HBV reactivation for HBsAg-positive cancer patients receiving chemotherapy. However, the real-world effectiveness and safety of TAF for cancer patients was lacing. Therefore, we conduct a prospective single arm study to evaluate the efficacy and safety of TAF as a prophylactic antiviral agent for HBsAg-positive cancer patients receiving chemotherapy.
详细描述
This prospective single arm study would be conducted in Taiwan. Patients who fulfill the inclusion criteria, will receive TAF before the initiation of systemic chemotherapy. Based on the guidance of NHI in Taiwan, prophylactic anti-viral agent should be prescribed within 7 days before chemotherapy and would be discontinued at 6 months after cessation of chemotherapy. The duration of TAF prophylaxis would be followed the guidance of NHI in Taiwan, however, the end of our observation would be at week 48 after TAF use. Patients will receive regular follow up at week 4, 12, 24, 36 and 48 (for T-bil, AST, ALT, creatinine, HBsAg, HBV DNA) till 1 year and the outcome will be collected. Platelet and HBcrAg would be examined at enrollment, 24 weeks and 48 weeks. HBeAg and anti-HBeAg will be examined at enrollment and 48 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (age ≥20) with positive HBsAg who are prepared to receive systemic chemotherapy
- •The presence of HBs antigen should be confirmed within recent two years
- •The patients who could receive systemic chemotherapy in 4 weeks
排除标准
- •Patients with poor performance status (Zubrod-ECOG ≥ 2 or Karnofsky score ≤ 70)
- •Patients with cirrhosis
- •Patients had eGFR lower than 15 ml/min/1.73m2 and didn't receive dialysis
- •Patients had exposure to any NUC or interferon within 6 months before chemotherapy
- •Patients were co-infected with HCV or HIV
- •Allergy history to any tenofovir-based medication
- •Pregnant woman
- •Unable to sign inform consent
研究组 & 干预措施
TAF prophylaxis
Using TAF to prevent HBV reactivation for HBsAg-positive cancer patients
干预措施: Tenofovir alafenamide (Drug)
结局指标
主要结局
The rate of HBV reactivation during TAF prophylaxis
时间窗: after 48 weeks of TAF use
Definition of HBV reactivation : 1. HBV DNA increase 2 log (100-fold) compared to the baseline level 2. HBV DNA 3 log (1,000) IU/mL in a patient with previously undetectable level 3. HBV DNA 4 log (10,000) IU/mL if the baseline level is not available
次要结局
- The dynamic change of eGFR during TAF prophylaxis(after 48 weeks of TAF use)