Reproducibility of Child-Turcotte-Pugh (CTP) Rating and NRL972 Pharmacokinetics in Patients With Cirrhosis
This is an open, randomized study in patients with different severity stages of hepatic cirrhosis, in which rater pairs will be used for the assessment of the intra- and inter-rater reproducibility of NRL972 pharmacokinetics and CTP sum score. Rating will be performed by 32 to 40 pairs of raters. The raters will perform the required assessments in the capacity of sub-investigators of the phase I (co-ordinating) unit.
Up to 240 patients with clinically established hepatic cirrhosis without confounding end-stage co-morbidity (stable disease) will be studied. Within 30 days of confirmation of eligibility, Visit 1 will take place to determine the investigational parameters (NRL972 pharmacokinetics, clinical laboratory tests, and determination of CTP sum score). At approximate intervals of one week, Visits 2, 3 and 4 will occur, and the investigational parameters will again be assessed.
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||An Open, Randomised Study to Compare the Reproducibility of CTP Rating and NRL972 Pharmacokinetics in Patient Volunteers With Hepatic Cirrhosis.|
- Comparison of the reproducibility of the CTP sum score with the reproducibility of the pharmacokinetics of NRL972, both assessed by a rater pair, in patients with stable hepatic cirrhosis. [ Time Frame: Up to 6 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||April 2009|
|Primary Completion Date:||December 2009 (Final data collection date for primary outcome measure)|
A single dose of 2 mg NRL972 will be administered on four occasions over a period of up to 6 weeks.
2 mg NRL972 in 5 mL solution for injection administered as a 15-second intravenous injection on each of four occasions.