龙用于治疗与慢性乙肝相关的肝纤维化:第三阶段随机试验的协议
Xiaobo Cai1, Yin Qu1, Wen Xie2
1Department of Gastroenterology, Shanghai General Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
Journal of clinical and translational hepatology
|May 19, 2025
概括
这一第三阶段试验研究了hydronidone对慢性乙型肝炎相关的肝纤维化. 预计这些结果将支持hydronidone作为一种有效的抗纤维菌治疗.
科学领域:
- 肝病学 肝病学是一种肝病学.
- 临床药理学 临床药理学
- 纤维化研究 纤维化研究
背景情况:
- 肝纤维化是慢性肝病进展的关键因素.
- 目前没有特定的抗纤维菌药物可用.
- 之前的第二阶段试验表明,当添加到恩特卡维尔时,水龙在逆转肝纤维化方面具有潜力.
研究的目的:
- 评估270毫克/天剂量氨治疗与慢性乙型肝炎 (CHB) 相关的肝纤维化的疗效.
- 进一步评估水龙在更大患者群体中的抗纤维素作用.
主要方法:
- 这是一项为期52周的随机,双盲,安慰剂控制,多中心的第三期临床研究.
- 包括与CHB相关的显著肝纤维化 (伊斯哈克评分≥3) 的成年患者 (18-65岁).
- 治疗包括安特卡维尔与氨 (270毫克/天) 或安慰剂结合使用.
主要成果:
- 主要终点是纤维化逆转的证明,定义为52周后伊斯哈克阶段得分下降≥1.
- 在水和安慰剂组之间的纤维化逆转的比较.
结论:
- 这项研究旨在提供强有力的证据,证明氨在治疗肝纤维化的有效性.
- 预计这些结果将支持hydronidone作为抗纤维素剂的新适应症.
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