Performance of Biochemical Response Criteria and Risk Scoring Systems in Chinese Patients With Primary Biliary Cholangitis (PBC) on Ursodeoxycholic Acid
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 试验地点
- 1
- 主要终点
- Liver related Death
研究概览
简要总结
Several risk assessment scoring systems have been proposed to assess the therapeutic response and predict long term prognosis in ursodeoxycholic acid (UDCA)-treated primary biliary cholangitis (PBC) patients, in order to risk stratify PBC patients and guide their management. However there scoring systems have not been fully validated in Chinese population. This study is going to compare the prognostic ability of these criteria, validate the overseas scoring systems, develop and validate a new scoring system in a cohort of Chinese PBC patients.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •With liver biopsy proved PBC
排除标准
- •A positive serological test for hepatitis B or C virus,
- •Comorbidity of primary sclerosing cholangitis,
- •Alcoholic liver disease,
- •Hemochromatosis,
- •Wilson's disease,
- •a1-antitrypsin deficiency
- •Presence of complications of cirrhosis (Total bilirubin >100 lmol/L, ascites, variceal haemorrhage and hepatic encephalopathy) on admission.
研究组 & 干预措施
PBC patients with liver biopsy
Ursodeoxycholic acid will be given compliance to the treatment guideline.
干预措施: Ursodeoxycholic Acid (Drug)
结局指标
主要结局
Liver related Death
时间窗: During follow-up after a year of starting UDCA, an average of 1 year
Whether the patients die from liver-related causes during the follow-up
次要结局
- Complications of cirrhosis(During follow-up after a year of starting UDCA, an average of 1 year)
- Liver transplant(During follow-up after a year of starting UDCA, an average of 1 year)