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

NCT00794482 | Completed Phase 3 DMC

• 1 other identifier: NRL972-03/2006 (CIR)
• Study Type: interventional
• Target: 1,200
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Hepatic Cirrhosis

Outcome Measures

Primary Outcomes (1)

• Influence of CTP staging on the pharmacokinetics of NRL972 in patients with cirrhosis.

  Single dose, 2-5 day follow-up

Secondary Outcomes (2)

• 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

Interventions

NRL972 DRUG

Single dose of 2 mg NRL972 administered intravenously. Total volume 5 mL.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Norgine: lead

Study Sites (1)

University Hospital

Essen, D-45147, Germany

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

NRL972

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 19, 2008
• First Posted: November 20, 2008
• Study Start: March 1, 2008
• Primary Completion: June 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 8, 2009

Record last verified: 2009-10

Locations

DE (1)