EUCTR2007-002404-18-AT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10月14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
- •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 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
- •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 definition of post-menopausal (either females with an age of >55 years plus 12 months of natural (spontaneous) amenorrhea or females with an age below 55 years plus 12 months of spontaneous amenorrhea with serum FSH levels >40 MIE/mL and oestrogen deficiency with a serum level of <30pg/mL or a negative oestrogen test) 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)
- •Special restrictions for the injection of lidocaine (MEGX test):
- •· Known hypersensitivity to local anaesthetics of the acid amide type
- •· Known or detected severe disturbances of the cardiac conduction system by clinical judgement or ECG findings
- •· Presence of acute decompensated cardiac insufficiency
- •Note: Subjects can be included into the study without the requirement to complete the MEGX test (lidocaine injection) based on the above exclusion criteria. In cases where the investigator intends to include patients without performing a MEGX-test for other reasons this must be approved by the sponsor prior to enrolment.
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