Impact of Enhanced Biochemical Response on Clinical Outcomes in Patients With Primary Biliary Cholangitis: A Bidirectional Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Rate of complication-free survival
研究概览
简要总结
This study is a bidirectional cohort study. The investigators conduct a bidirectional cohort study utilizing a database in mainland China, continuously collecting demographics, clinical symptoms, and biochemical characteristics of diagnosed PBC patients.
The study aims to analyze the association between varying post-treatment alkaline phosphatase (AKP) levels and complication-free survival rates, with the objective to develop and validate a predictive survival model.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age above 18 years old, Male or Female,
- •Diagnosis of PBC meeting the 2018 American Association for the Study of Liver Diseases (AASLD) Practice Guidelines criteria;
- •Treatment with UDCA at a standard dose (13-15 mg/kg/day), with or without other second-line medications.
排除标准
- •Co-existing liver diseases, including but not limited to: Hepatitis C virus infection; Active Hepatitis B infection (patients who are HBsAg-negative and HBeAg-negative may be considered eligible per investigator assessment);
- •Autoimmune Hepatitis (AIH); Primary Sclerosing Cholangitis (PSC); Suspected or confirmed hepatocellular carcinoma;
- •Female subjects who is pregnant or breastfeeding during the study;
- •History of other malignancies, including hematological tumors, solid tumors except hepatobiliary system;
- •Poor adherence or inability to complete the study follow-up.
研究组 & 干预措施
Group 1: AKP<1*ULN
Patients diagnosed with PBC whose AKP levels fall below the upper limit of normal (ULN) after 12 months of treatment.
干预措施: Only observation (Other)
Group 2: AKP<1.67*ULN and >1*ULN
Patients diagnosed with PBC whose AKP levels are between 1* and 1.67*ULN after 12 months of treatment.
干预措施: Only observation (Other)
Group 3: AKP>1.67*ULN
Patients diagnosed with PBC whose AKP levels exceed 1.67*ULN after 12 months of treatment.
干预措施: Only observation (Other)
结局指标
主要结局
Rate of complication-free survival
时间窗: 18 months
Complication-free survival, defined as survival without liver-related death caused by PBC, liver transplantation, or major liver-related complications (ascites, variceal bleeding, hepatic encephalopathy, or hepatocellular carcinoma) during follow-up.
次要结局
未报告次要终点
研究者
ma xiong
Principal Investigator
RenJi Hospital