Placebo-controlled Study of NPB-06 in Patients With Portal Vein Thrombosis
Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
Patients with portal vein thrombosis, who have chronic liver diseases especially liver
cirrhosis associated with low levels of AT III, will receive intravenous injection of NPB-06
or placebo. The superiority of NPB-06 to placebo as anticoagulative agent will be verified in
a randomized, double-blind, parallel-assignment design based on the proportion of patients
obtained complete recanalization or partial recanalization of portal vein thrombosis.
The safety of NPB-06 will be evaluated based on adverse events and adverse drug reactions
(ADRs) observed between administration and 21 days after administration in comparison with
the placebo group.