Observational, Post-marketing Renal Safety Surveillance Registry in Subjects With Chronic Hepatitis B (HBV) Infection With Decompensated Liver Disease Receiving Nucleotide/Side Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 27
- 主要终点
- Proportion of participants with a confirmed increase in serum creatinine from baseline of at least one grade
研究概览
简要总结
This registry will remain open for approximately 5 years (4 years of enrollment + 1 year of follow up). Subjects will be followed until Orthotopic Liver Transplant (OLT), resolution of liver decompensation, death, or conclusion of the registry.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Estimated glomerular filtration rate (Cockcroft-Gault method)using actual body weight of ≥ 50 mL/min at time of entry into registry
- •Negative serologies for HIV, hepatitis C virus (HCV), and/or hepatitis D virus (HDV)
- •No history of solid organ or bone marrow transplant
- •Currently receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy within 6 months of inclusion into registry
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
排除标准
- 未提供
研究组 & 干预措施
Participants with chronic HBV infection
Participants with decompensated liver disease due to chronic HBV infection, who are receiving or anticipated to receive anti-HBV nucleoside/nucleotide therapy, will be included in the study.
干预措施: Anti-HBV nucleoside/nucleotide therapy (Drug)
结局指标
主要结局
Proportion of participants with a confirmed increase in serum creatinine from baseline of at least one grade
时间窗: Baseline to Year 5
The proportion of participants with a confirmed increase in serum creatinine of at least one grade will be calculated as the number of participants with at least one grade increase in serum creatinine from baseline divided by the total number of subjects enrolled over the 4 years of accrual.
次要结局
- Proportion of participants with a confirmed increase in serum creatinine from baseline of at least one grade evaluated using the competing risk cumulative incidence framework(Baseline to Year 5)
- Proportion of participants with at least one confirmed estimated glomerular filtration rate (eGFR) below 50 mL/min(Baseline to Year 5)
- Change in eGFR compared to eGFR at baseline by visit window(Baseline to Year 5)
- Proportion of participants who received appropriate dosing relative to renal function(Baseline to Year 5)
- Proportion of participants who discontinued anti-hepatitis B virus (HBV) nucleoside/nucleotide therapy due to a renal related event(Baseline to Year 5)
- Proportion of participants with at least one change in model for end stage liver disease (MELD) score compared to baseline(Baseline to Year 5)
- Change in MELD score and liver disease status compared to MELD score at baseline by visit window(Baseline to Year 5)
- Proportion of participants with at least one plasma HBV DNA < 400 copies/mL (69 IU/mL)(Baseline to Year 5)
- The median number of renal related adverse events per participant over the evaluation period(Baseline to Year 5)