Multi-national Cirrhosis Study to Characterise the Association Between the Pharmacokinetics of NRL972 and Disease Severity.

This study has been completed.
Sponsor:
Information provided by:
Norgine
ClinicalTrials.gov Identifier:
NCT00794482
First received: November 19, 2008
Last updated: October 7, 2009
Last verified: October 2009
  Purpose

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.


Condition Intervention Phase
Hepatic Cirrhosis
Drug: NRL972
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: A Multi-centre, Multi-national Open Study in Patients With Hepatic Cirrhosis to Characterise the Association Between the Pharmacokinetics of NRL972 and Disease Severity.

Resource links provided by NLM:


Further study details as provided by Norgine:

Primary Outcome Measures:
  • Influence of CTP staging on the pharmacokinetics of NRL972 in patients with cirrhosis. [ Time Frame: Single dose, 2-5 day follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Inter-subject relationship between the pharmacokinetics of NRL972 and other parameters used to define the severity of hepatic cirrhosis [ Time Frame: 2-5 days ] [ Designated as safety issue: No ]
  • To assess the safety and tolerability of 2mg NRL972 administered by intravenous injection to patients with hepatic cirrhosis [ Time Frame: 2-5 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 1200
Study Start Date: March 2008
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: NRL972
    Single dose of 2 mg NRL972 administered intravenously. Total volume 5 mL.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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 Criteria:

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794482

Locations
Germany
University Hospital
Essen, Germany, D-45147
Sponsors and Collaborators
Norgine
  More Information

No publications provided

Responsible Party: Vice President, Clinical Development, Norgine Ltd
ClinicalTrials.gov Identifier: NCT00794482     History of Changes
Other Study ID Numbers: NRL972-03/2006 (CIR)
Study First Received: November 19, 2008
Last Updated: October 7, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
Italy: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: FSI Scientific Center of Expertise of Medical Application
Romania: Ministry of Public Health
Lithuania: State Medicine Control Agency - Ministry of Health
Bulgaria: Bulgarian Drug Agency
Serbia and Montenegro: Agency for Drugs and Medicinal Devices

Additional relevant MeSH terms:
Liver Cirrhosis
Fibrosis
Liver Diseases
Digestive System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 22, 2014