相关实验视频

Updated: Mar 15, 2026

A Competent Hepatocyte Model Examining Hepatitis B Virus Entry through Sodium Taurocholate Cotransporting Polypeptide as a Therapeutic Target

A Competent Hepatocyte Model Examining Hepatitis B Virus Entry through Sodium Taurocholate Cotransporting Polypeptide as a Therapeutic Target

Published on: May 10, 2022

治愈慢性乙型肝炎的临床试验:对试验设计考虑因素及其与试验性能相关性的全面分析

Lichen Shi^1,2, Hao Wang^1,3,4, Cheng Huang^1,2

¹Clinical Epidemiology and EBM Unit, Beijing Clinical Research Institute, Beijing Friendship Hospital, Capital Medical University, Beijing, China.

Journal of gastroenterology and hepatology

|March 14, 2026

概括

较小,较短的慢性乙型肝炎 (CHB) 治愈早期试验更有可能完成. 直接作用的抗病毒药物在显著的乙型肝炎表面抗原 (HBsAg) 降低方面表现有前途,表明潜在但尚未具有功能治愈.

科学领域:

肝病学和病毒性肝炎的研究研究.
临床试验设计和分析.
开发用于传染病的药物开发.

背景情况:

加速开发用于治疗慢性乙型肝炎 (CHB) 的新药.
对CHB治疗候选药物的有限过渡到III期试验.
需要评估影响完成和阶段过渡的试验设计特征.

研究的目的:

评估与注册表定义的完成和CHB治疗试验阶段过渡相关的试验设计特征.
合成治疗结束时的乙型肝炎表面抗原 (HBsAg) 降低作为治疗中的抗病毒信号.

主要方法:

对CHB治疗试验的临床试验注册表和文献数据库的系统审查.
对于时间到注册表定义完成的考克斯回归.
对于从I阶段过渡到II阶段的物流回归.
随机效应对治疗结束时HBsAg下降的元分析.

主要成果:

较小的样本大小和较短的治疗时间与第一阶段CHB治疗试验中更高的完成率相关.
在II期试验中,更大的样本大小与更低的完成概率有关.
新的试验设计没有加速完成.
与健康志愿者的试验更有可能进入第二阶段.
直接作用抗病毒药物在治疗结束时显示出显著的HBsAg下降.

结论:

早期CHB治愈试验受益于更小的规模和更短的完成时间.
新型设计不能保证更快的试验进展.
直接作用抗病毒药物在治疗期间显示出强烈的HBsAg下降信号,与功能治愈不同.

关键词:

在HBsAg下降.慢性乙型肝炎慢性乙型肝炎临床试验是指临床试验中的临床试验.新型治疗剂新型治疗剂试验设计试验设计.

更多相关视频

Author Spotlight: Advancements and Challenges in Hepatitis B Virus Detection

Author Spotlight: Advancements and Challenges in Hepatitis B Virus Detection

Published on: December 15, 2023

A Three-Dimensional Spheroid Model to Investigate the Tumor-Stromal Interaction in Hepatocellular Carcinoma

A Three-Dimensional Spheroid Model to Investigate the Tumor-Stromal Interaction in Hepatocellular Carcinoma

Published on: September 30, 2021

相关概念视频

Clinical Trials

Clinical Trials

Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches

Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast,...

Clinical Trials: Overview

Clinical Trials: Overview

Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...

Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test

Effect of Hepatic Disease on Pharmacokinetics: Pathophysiologic Assessment and Liver Function Test

In clinical practice, the direct measurement of hepatic blood flow to evaluate liver function presents significant challenges due to the intricate and specialized nature of the necessary techniques. Consequently, healthcare professionals often rely on empirical estimates derived from thorough patient examinations and liver function tests to gauge liver health. Among the tools at their disposal, the Child–Pugh and MELD scoring systems stand out for their ability to categorize and assess...

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability Study Design: Healthy Subjects Versus Patients

Bioavailability studies are essential for evaluating a drug's therapeutic efficacy and understanding its absorption patterns under various physiological conditions. Conducting such studies on target patient populations provides more relevant data by simulating real-world disease states. However, practical challenges often necessitate the use of young, healthy adult volunteers as study subjects.Patients may exhibit altered drug absorption patterns due to the effects of the disease itself,...

Hazard Ratio

Hazard Ratio

The hazard ratio (HR) is a widely used measure in clinical trials to compare the risk of events, such as death or disease recurrence, between two groups over time. It reflects the ratio of hazard rates—the instantaneous risk of the event occurring—between a treatment group and a control group. This measure provides valuable insights into the relative effectiveness of a treatment by assessing how the risk of an event differs between the two groups.
For example, in a clinical trial...