Multi-national Cirrhosis Study to Characterise the Association Between the Pharmacokinetics of NRL972 and Disease Severity.
Status:
Completed
Trial end date:
2009-06-01
Target enrollment:
Participant gender:
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.