EUCTR2007-002404-18-DE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 1,400 人开始时间: 2007年12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
- 1,400
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
- •Subjects meeting the following conditions will be eligible for enrolment:
- •Patient has given his/her written informed consent to the study participation, prior to study specific procedures
- •Male and female (non-child-bearing potential = post-menopausal or medically adequate contraception)
- •Ethnicity: any
- •Age: 18 to 80 years of age
- •Patients with histological established diagnosis of hepatic cirrhosis and available histological material for review by the central histopathologist. In the case of a CTP score = 10 points the histological confirmation of hepatic cirrhosis and available histological material for review can be replaced by an objective imaging study (CT or NMR scan) within 3 months of the screening visit confirming hepatic cirrhosis (scans are collected and reviewed). Patients with the diagnosis of primary biliary cirrhosis, primary sclerosing cholangitis and cystic fibrosis-associated liver disease are to be excluded.
- •Present CTP-class A, B or C
- •Medically fit to undergo the protocol-defined procedures without undue risk and discomfort
- •Predicted life-expectancy of greater than or equal to 6 months by 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
- •Subjects of any of the following categories will be excluded from enrolment:
- •Previous participation in this trial (except for scheduled re-testing in relation to technical difficulties with initial test)
- •Participant in any other trial during the last 90 days
- •Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months
- •Any donation of germ cells, blood, organs, or bone marrow during the course of the study
- •History of any clinically relevant allergy (including hypersensitivity to the trial medications)
- •Presence of clinical relevant acute or chronic infection (other than chronic viral hepatitis, if applicable)
- •Use of confounding concomitant medication (see Section 7.5.7)
- •Presence or history of any end-stage (co-)morbidity (excluding the effects of hepatic cirrhosis) such as: malignancy and clinically relevant systemic diseases
- •Suspicion or evidence that the subject is not trustworthy and reliable
- •Suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard
- •Primary biliary cirrhosis and primary sclerosing cholangitis
- •Cystic fibrosis
- •Previous liver transplantation or intended liver transplantation within 6 months after enrolment
- •Patients having undergone previous transjugular intrahepatic portosystemic shunt (TIPS) or portocaval anastomosis (PCA)
- •Patients who are employees at the investigational site, relatives or spouses of the investigator
- •Current drug, or medication abuse
- •Special restrictions for female patients:
- •Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation.
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, including women whose career, lifestyle, or sexual orientation precludes intercourse with a male partner and women whose partners have been sterilized by vasectomy or other means, unless they meet the following definition of post-menopausal: 12 months of natural (spontaneous) amenorrhea or 6 months of spontaneous amenorrhea with serum FSH levels >40 mIU/m or 6 weeks post surgical bilateral oophorectomy with or without hysterectomy or hysterectomy or are using one or more of the following acceptable methods of contraception: surgical sterilization (e.g., bilateral tubal ligation, vasectomy), hormonal contraception (implantable, patch, oral), and double-barrier methods (any double combination of: IUD, male or female condom with spermicidal gel, diaphragm, sponge, cervical cap)
研究者
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