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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
72
5 days continuous-infusion
5 days continuous-infusion
Unnamed facility
Chūbu, Japan
Unnamed facility
Hokkaido, Japan
Unnamed facility
Kanto, Japan
Unnamed facility
Kyushu, Japan
Unnamed facility
Osaka, Japan
The proportion of patients obtained complete recanalization or partial recanalization of portal vein thrombosis
Contrast enhanced CT assessed by an independent radiologist
Time frame: an expected average of 2 weeks
The proportion of patients obtained complete recanalization of portal vein thrombosis
Time frame: an expected average of 2 weeks
Reduction rate of portal vein thrombosis
Time frame: Up to 3 weeks
Improvement of Child-Pugh score
Time frame: Up to 5 weeks
Changes in laboratory values (congealing fibrinogenolysis system)
Time frame: Up to 5 weeks
Adverse events and adverse drug reactions observed between administration and 21 ± 3 days after administration
Time frame: Up to 5 weeks
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