Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated With Nucleoside/Nucleotide Monotherapy for Patients With Chronic HBV Infection: The REALM Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12,522
- 试验地点
- 21
- 主要终点
- Number of Participants With Liver-related HBV Disease Progression
研究概览
简要总结
The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection. For the China substudy, patients randomized to entecavir will have safety and efficacy assessments performed during the first year of the study.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic HBV infection
- •HBV nucleoside/tide-naive or -experienced
- •Patients who, in opinion of investigator, are appropriate for initiating or modifying their HBV therapy and who are appropriate for a treatment regimen comprised of nucleoside/tide monotherapy with either ETV or another standard of care HBV nucleoside/tide analogue
- •Age 16 and older or minimum age required in a given country
排除标准
- •Women who are pregnant or breastfeeding
- •Patients who, in the opinion of the investigator, are expected to have a liver transplant-free survival of less than one year
- •Patients who, in the opinion of the investigator, are virologically controlled on their current treatment regimen and clinically responding to treatment, unless the regimen needs to be modified for medication intolerance
- •Coinfection with HIV
- •History of malignant neoplasm(s), including hepatocellular carcinoma (HCC) and carcinoma in situ (CIS), but excluding non-melanoma skin cancers
- •Patients with chronic renal insufficiency, defined as a creatinine clearance < 50 ml/min who do not have either of the following means of dose reducing ETV:
- •i. an approved country-specific ETV label which includes the extended interval ETV dose modification method and/or ii. an approved country specific label for the ETV oral solution AND access to the oral solution
- •History of dysplastic liver nodules
- •Known history of allergy to nucleoside/tide analogues
- •Prior or current treatment with entecavir
- •An investigator proposed study regimen which will include only interferon-alfa
- •An investigator proposed study regimen of combination (two or more) HBV nucleoside/tide analogues
研究组 & 干预措施
A
干预措施: entecavir (Drug)
B
干预措施: Other anti-HBV medication (Drug)
结局指标
主要结局
Number of Participants With Liver-related HBV Disease Progression
时间窗: 10 years
The number of participants with Liver-related HBV disease progression, as adjudicated by Events Adjudication Committee (EAC)
Number of Participants With Adjudicated Overall Malignant Neoplasms
时间窗: 10 years
The number of participants with Overall Malignant Neoplasm, as adjudicated by Events Adjudication Committee (EAC)
Number of Deaths
时间窗: 10 years
The number of deaths, as adjudicated by Events Adjudication Committee (EAC)
次要结局
- Number of Participants With HCC Malignant Neoplasm(10 years)
- Number of Participants With Non-HCC Malignant Neoplasm(10 years)
- Number of Participants With Liver-related Death(10 years)