Long-term Safety and Efficacy of Tenofovir Amibufenamide in Patients With HBeAg-positive or HBeAg-negative Chronic Hepatitis B - a Multicenter, Open-label Follow-up Study
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 640
- 试验地点
- 1
- 主要终点
- Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA lower than in the central laboratory
研究概览
简要总结
Tenofovir amibufenamide (TMF) is a novel prodrug of tenofovir that has been widely used in mainland China for the treatment of chronic hepatitis B (CHB). The previous registrational study (NCT03903796) has established the non-inferior virologic efficacy of TMF to tenofovir disoproxil fumarate (TDF), while demonstrating higher rates of alanine aminotransferase (ALT) normalization and improved bone and renal safety profiles. This study presented the long-term efficacy and safety of TMF in a phase IV study.
详细描述
Participants from the Phase III registrational trial of TMF were enrolled and followed for another seven years, starting at week 144 in the Phase III study as the baseline. Once-daily oral dose of 25 mg TMF were maintained in all participants. Clinical assessments were conducted every 24 weeks. The primary efficacy endpoint was the percentage of patients with serum HBV DNA levels below the quantification limit at week (144+) 96.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with HBeAg-positive or HBeAg-negative chronic hepatitis B who completed a pivotal Phase III clinical study of HS-10234-301
排除标准
- •Completion of HS-10234-301 pivotal Phase III clinical study Interruption of TMF treatment for more than 24 weeks or continuous use of alternative, commercially available hepatitis B antivirals for more than 24 weeks (Participants who have discontinued TMF for more than 24 weeks can only be enrolled in this study after investigator evaluation and confirmation) 2）Evidence of hepatocellular carcinoma (e.g. as evidenced by recent imaging). 3)significant bone disease (e.g. osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochrondroses), or multiple bone fractures.
- •4）Currently receiving therapy with immunomodulators (e.g. corticosteroids), investigational agents, nephrotoxic agents, or agents capable of modifying renal excretion.
- •5）Known hypersensitivity to study drugs, metabolites, or formulation excipients.
- •In the investigator's judgment, current alcohol or substance abuse may interfere with the subject's compliance with the study requirements 7）Current alcohol or substance abuse judged by the investigator to potentially interfere with participant compliance.
研究组 & 干预措施
TMF treatment group
干预措施: Tenofovir Amibufenamide（TMF） (Drug)
结局指标
主要结局
Evaluation the percentage of Participants with Hepatitis B Virus (HBV) DNA lower than in the central laboratory
时间窗: week (144+)96
The primary efficacy endpoint was the proportion of patients with HBV DNA lower than in the central laboratory at week (144+)96.
次要结局
- The proportion of subjects with HBV DNA with lower than in the central laboratory(week(144+)240、week(144+)336)
- Proportion of subjects with ALT normalization rate(week (144+)96、week (144+)240、week (144+)336)
- Proportion of Patients Achieving HBsAg loss，HBsAg conversion(week (144+)96、week (144+)240、week (144+)336)
- Incidence of resistance mutation(week (144+)96、week (144+)240、week (144+)336)
- Progression of liver disease associated with HBV infection(week (144+)96、week (144+)240、week (144+)336)
- Proportion of Patients Achieving HBeAg loss，HBeAg conversion ratio(week (144+)96、week (144+)240、week (144+)336)
- Percent Change from Baseline in Hip and spine Bone Mineral Density (BMD)(week (144+)96、week (144+)240、week (144+)336)
- Change from Baseline in Serum Creatinine(week (144+)96、week (144+)240、week (144+)336)
- Change in HBV DNA from baseline(week (144+)96、week (144+)240、week (144+)336)