A Single-center, Prospective, Randomized, Open-label, Comparative, Investigator-initiated Clinical Trial to Confirm the Non-inferiority and Safety of Tenofovir Alafenamide and Tenofovir Disoproxil Fumarate in Patients With Hematologic Malignancies Who Require Prophylactic Hepatitis B Antiviral Treatment
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- Proportion of subjects maintained at HBV DNA <29 IU/mL
研究概览
简要总结
his clinical trial was conducted to determine the non-inferiority and safety of prophylactic antiviral treatment of Tenofovir alafenamide (TAF) compared to Tenofovir disoproxil fumarate (TDF) in patients with malignant hematological diseases requiring prophylactic hepatitis B antiviral treatment. Confirm.
In the case of TAF, domestic evidence when used as a first-line treatment is insufficient, so in this clinical trial, the virus suppression effect compared to TDF during the first administration of TAF to patients with malignant hematological diseases requiring prophylactic hepatitis B antiviral treatment was investigated. We aim to secure non-inferiority and additionally confirm the safety of TAF's known advantages of reducing renal function damage and protecting bone function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult men and women over 19 years of age and under 65 years of age
- •Patients who meet the following criteria A or B A. Those scheduled for hematopoietic stem cell transplantation and treatment with immunosuppressants or chemotherapy.
- •B. Those scheduled to receive anticancer treatment including rituximab
- •HBcAb positive patient
- •Patients who voluntarily agreed to participate in this clinical trial and signed a written consent form
排除标准
- •Patients taking oral chronic hepatitis B antiviral drugs before starting the study
- •Galactose intolerance. Patients with genetic problems such as Lapp lactase deficiency or glucose-galactose malabsorption
- •Patients with hypersensitivity to tenofovir alafenamide citrate or tenofovir disoproxil orotate
- •Patients with abnormal renal function (e-GFR less than 15mL/min) or end-stage renal disease requiring dialysis
- •Hepatitis C patients
- •HIV-infected patients
- •Pregnant women, lactating women, or patients planning to become pregnant
- •If you are participating in another clinical trial administering medication
- •Patients who do not agree to participate in this clinical trial
- •Adults with impaired consent capacity who are unable to give consent on their own
- •Those who have taken other clinical trial drugs for less than 24 weeks
- •Other clinically determined by the principal investigator to be difficult for the clinical trial subject to conduct the clinical trial.
研究组 & 干预措施
TAF group
干预措施: Vemlidy (Drug)
TDF group
干预措施: Virreal (Drug)
结局指标
主要结局
Proportion of subjects maintained at HBV DNA <29 IU/mL
时间窗: 48 weeks
次要结局
- Proportion of subjects maintaining HBV DNA <10 IU/mL(12, 24, 48, 72 weeks)
- creatinine clearance rate(12, 24, 48, 72 weeks)
- Proportion of subjects maintaining HBV DNA <29 IU/mL(72 weeks)
- total cholesterol, LDL-cholesterol, HDL-cholesterol, triglyceride(12, 24, 48, 72 weeks)
- Proportion of subjects with serum HBV DNA <60 IU/mL(12, 24, 48, 72 weeks)
- Level of AST, ALT, r-GTP(12, 24, 48, 72 weeks)
- level of e-GFR(12, 24, 48, 72 weeks)
- BMD T Score(24, 48, 72 weeks)
- blood Phosphorus levels(12, 24, 48, 72 weeks)