EUCTR2007-002404-18-IT进行中（未招募）不适用
A multi-centre, multi-national open study in patients with hepatic cirrhosis to characterise the association between the pharmacokinetics of NRL972 and disease severity - NRL972 in hepatic cirrhosis
ORGINE LIMITED0 个研究点目标入组 1,200 人开始时间: 2008年6月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 1,200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Patients with histologically established diagnosis of hepatic
- •cirrhosis and available histological material for review by the
- •central histopathologist or a CTP score ≥ 10 points plus an
- •objective imaging study (CT or NMR scan) within 3 months of the
- •screening visit with a confirmation of hepatic cirrhosis (scans are
- •collected and reviewed), but excluding patients with the diagnosis
- •of primary biliary cirrhosis, primary sclerosing cholangitis and
- •cystic fibrosis-associated liver disease
- •Present CTP-class A, B or C
- •NO previous liver transplantation or intended liver transplantation
- •within the next 6 months after enrolment
- •NO previous transjugular intrahepatic portosystemic shunt (TIPS)
- •or portocaval anastomosis (PCA)
- •Medically fit to undergo the protocol-defined procedures without
- •undue risk and discomfort
- •Predicted life-expectancy ≥ 6 months based on clinical judgement
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •patients with the diagnosis of primary biliary cirrhosis, primary sclerosing cholangitis and cystic fibrosis-associated liver disease NO previous liver transplantation or intended liver Transplantation within the next 6 months after enrolment NO previous transjugular intrahepatic portosystemic shunt (TIPS) or portocaval anastomosis (PCA)
研究者
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