Placebo-controlled Study of NPB-06 in Patients With Portal Vein Thrombosis
- Registration Number
- NCT02250391
- Lead Sponsor
- Nihon Pharmaceutical Co., Ltd
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 72
Inpatients or outpatients meet the criteria (1)-(4) below will be enrolled in the study. Patients have to provide written informed consent for voluntary participation in the study.
- Patients who the serum level of AT-III is 70% or less
- Patients with portal vein thrombosis detected by ultrasonography
- Patients who have more than 50% of the thrombus lumen occupancy
- Patients who are older than 20 years at the time of consent
Patients who meet any of the following criteria will be excluded from the study beforehand.
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Patients with tumor embolus in portal vein
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Patients with an ongoing hepatic intra-arterial chemotherapy such as implantable reservoir system
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Patients with hepatocellular cancer of more than 3 cm in diameter or more than four hepatocellular cancers
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Patients with residual or chronic portal vein thrombosis
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Patients with advanced liver disease (Child-Pugh score 11 or more)
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Patients with bleeding tendency
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Patients who had an anticoagulation therapy (intravenous or subcutaneous dose) or hemostasis with an enzymatic hemostatic agent in the period between 7 days before contrast enhanced CT of pre-dose and the day acquired written informed consent
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Patients who had an anticoagulation therapy (oral dose) in the period between 7 days before contrast enhanced CT of pre-dose and the day acquired written informed consent
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Patients with a history of shock or hypersensitivity to NPB-06
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Patients with inappropriate to contrast agents
- A history of allergy of iodine or X-ray contrast agent
- Complication of serious thyroid disease
- Reduced renal function
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Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
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Patients who have received NPB-06
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Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
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Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description NPB-06 NPB-06 1,500 unit, 5 days continuous-infusion Placebo Placebo 0 unit, 5 days continuous-infusion
- Primary Outcome Measures
Name Time Method The proportion of patients obtained complete recanalization or partial recanalization of portal vein thrombosis an expected average of 2 weeks Contrast enhanced CT assessed by an independent radiologist
- Secondary Outcome Measures
Name Time Method The proportion of patients obtained complete recanalization of portal vein thrombosis an expected average of 2 weeks Reduction rate of portal vein thrombosis Up to 3 weeks Improvement of Child-Pugh score Up to 5 weeks Changes in laboratory values (congealing fibrinogenolysis system) Up to 5 weeks Adverse events and adverse drug reactions observed between administration and 21 ± 3 days after administration Up to 5 weeks