Status:
COMPLETED
Multi-national Cirrhosis Study to Characterise the Association Between the Pharmacokinetics of NRL972 and Disease Severity.
Lead Sponsor:
Norgine
Conditions:
Hepatic Cirrhosis
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
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 p...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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)
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
1200 Patients enrolled
Trial Details
Trial ID
NCT00794482
Start Date
March 1 2008
End Date
June 1 2009
Last Update
October 8 2009
Active Locations (1)
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1
University Hospital
Essen, Germany, D-45147