EUCTR2007-002404-18-BG进行中（未招募）不适用
A multi-centre, multi-national open study in patients with hepatic cirrho-sis to characterise the association between the pharmacokinetics of NRL972 and disease severity
orgine Limited0 个研究点目标入组 1,200 人开始时间: 2008年8月1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:
- •1.Patient has given his/her written informed consent to the study participation, prior to study specific procedures.
- •2. Male and female (non-child-bearing potential = post-menopausal or medically adequate contraception).
- •3. Ethnicity: any.
- •4. Age: 18 to 80 years of age.
- •5. 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
- •6. Present CTP-class A, B or C
- •7. Medically fit to undergo the protocol-defined procedures without undue risk and discomfort
- •8. 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:
- •1. Previous participation in this trial (except for scheduled re-testing in relation to technical difficulties with initial test).
- •2. Participant in any other trial during the last 90 days.
- •3. Donation of blood during the last 60 days or a history of blood loss exceeding 300 mL within the last 3 months.
- •4. Any donation of germ cells, blood, organs, or bone marrow during the course of the study.
- •5. History of any clinically relevant allergy (including hypersensitivity to the trial medications).
- •6. Presence of clinical relevant acute or chronic infection (other than chronic viral hepatitis, if applicable).
- •7. Use of confounding concomitant medication (see Section 7.5.7).
- •8. Presence or history of any end-stage (co-)morbidity (excluding the effects of hepatic cirrhosis) such as: malignancy and clinically relevant systemic diseases
- •9. Suspicion or evidence that the subject is not trustworthy and reliable.
- •10. Suspicion or evidence that the subject is not able to make a free consent or to understand the information in this regard
- •11. Primary biliary cirrhosis and primary sclerosing cholangitis
- •Cystic fibrosis
- •12. Previous liver transplantation or intended liver transplantation within 6 months after enrolment
- •13. Patients having undergone previous transjugular intrahepatic portosystemic shunt (TIPS) or portocaval anastomosis (PCA)
- •14. Patients who are employees at the investigational site, relatives or spouses of the investigator
- •15. Current drug, or medication abuse
- •16. 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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