Hepatic Cirrhosis Clinical Trial
Official title:
An Open, Randomised Study to Compare the Reproducibility of CTP Rating and NRL972 Pharmacokinetics in Patient Volunteers With Hepatic 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.
n/a
Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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