Multi-national Cirrhosis Study to Characterise the Association Between the Pharmacokinetics of NRL972 and Disease Severity.
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.
|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.|
- 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 ]
- 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 ]
|Study Start Date:||March 2008|
|Study Completion Date:||June 2009|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00794482
|Essen, Germany, D-45147|