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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 22, 2014