Status:
COMPLETED
Placebo-controlled Study of NPB-06 in Patients With Portal Vein Thrombosis
Lead Sponsor:
Nihon Pharmaceutical Co., Ltd
Conditions:
Portal Vein Thrombosis
Eligibility:
All Genders
20+ years
Phase:
PHASE3
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 supe...
Eligibility Criteria
Inclusion
- 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
Exclusion
- Patients who meet any of the following criteria will be excluded from the study beforehand.
- Patients with tumor embolus in portal vein
- Patients with an ongoing hepatic intra-arterial chemotherapy such as implantable reservoir system
- Patients with hepatocellular cancer of more than 3 cm in diameter or more than four hepatocellular cancers
- Patients with residual or chronic portal vein thrombosis
- Patients with advanced liver disease (Child-Pugh score 11 or more)
- Patients with bleeding tendency
- 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
- 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
- Patients with a history of shock or hypersensitivity to NPB-06
- 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
- Pregnant or lactating women, women of childbearing potential, or women who plan to become pregnant during the study
- Patients who have received NPB-06
- Patients who have received other investigational drugs within four months before consent or who are participating in other clinical studies
- Patients otherwise ineligible for participation in the study in the investigator's or subinvestigator's opinion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT02250391
Start Date
September 1 2014
End Date
March 1 2016
Last Update
September 9 2016
Active Locations (5)
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1
Chūbu, Japan
2
Hokkaido, Japan
3
Kanto, Japan
4
Kyushu, Japan