NCT00794482已完成3 期
A Multi-centre, Multi-national Open Study in Patients With Hepatic Cirrhosis to Characterise the Association Between the Pharmacokinetics of NRL972 and Disease Severity.
Norgine2 个研究点 分布在 1 个国家目标入组 1,200 人开始时间: 2008年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,200
- 试验地点
- 2
- 主要终点
- Influence of CTP staging on the pharmacokinetics of NRL972 in patients with cirrhosis.
研究概览
简要总结
This is a multi-centre, multi-national, open study to assess the pharmacokinetics of NRL972 in patients with hepatic cirrhosis CTP-classes A, B, and C (histologically confirmed by liver biopsy). The pharmacokinetics of NRL972 will be referenced to a Clinical Staging Matrix obtained during a clinical work-up of patients with hepatic cirrhosis. Patients to be studied will have histologically established hepatic cirrhosis or confirmed hepatic cirrhosis by an objective imaging study without confounding end-stage co-morbidity. Within 14 days of confirming eligibility, the investigations will be conducted over 2-5 days with the test procedures (clinical laboratory tests, ultrasound (US)-investigations, gastroscopy, NRL972- and MEGX'-test). Up to one week after the NRL972-test, a follow-up telephone call will be made.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects meeting the following conditions will be eligible for enrolment:
- •Patient has given his or 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 greater than or equal to 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 greater than or equal to 6 months by clinical judgement
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
- •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 greater than 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)
结局指标
主要结局
Influence of CTP staging on the pharmacokinetics of NRL972 in patients with cirrhosis.
时间窗: Single dose, 2-5 day follow-up
次要结局
- Inter-subject relationship between the pharmacokinetics of NRL972 and other parameters used to define the severity of hepatic cirrhosis(2-5 days)
- To assess the safety and tolerability of 2mg NRL972 administered by intravenous injection to patients with hepatic cirrhosis(2-5 days)
研究者
研究点 (2)
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