NCT02250391

Placebo-controlled Study of NPB-06 in Patients With Portal Vein Thrombosis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 72 (actual)
• Sponsor: Nihon Pharmaceutical Co., Ltd · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Portal Vein Thrombosis

Interventions

Type	Name	Description
DRUG	NPB-06	5 days continuous-infusion
DRUG	Placebo	5 days continuous-infusion

Timeline

• Start date: 2014-09-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-09-26
• Last updated: 2016-09-09

Locations

5 sites across 1 country: Japan