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

Primary Purpose

Portal Vein Thrombosis

Status

Completed

Phase

Phase 3

Locations

Japan

Study Type

Interventional

Intervention

NPB-06

Placebo

About this trial

This is an interventional treatment trial for Portal Vein Thrombosis

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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 Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

NPB-06

Placebo

Arm Description

1,500 unit, 5 days continuous-infusion

0 unit, 5 days continuous-infusion

Outcomes

Primary Outcome Measures

The proportion of patients obtained complete recanalization or partial recanalization of portal vein thrombosis

Contrast enhanced CT assessed by an independent radiologist

Secondary Outcome Measures

The proportion of patients obtained complete recanalization of portal vein thrombosis

Reduction rate of portal vein thrombosis

Improvement of Child-Pugh score

Changes in laboratory values (congealing fibrinogenolysis system)

Adverse events and adverse drug reactions observed between administration and 21 ± 3 days after administration

Full Information

NCT ID

NCT02250391

First Posted

September 20, 2014

Last Updated

September 7, 2016

Sponsor

Nihon Pharmaceutical Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT02250391

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

March 2016 (Actual)

Study Completion Date

March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Nihon Pharmaceutical Co., Ltd

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Portal Vein Thrombosis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

72 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NPB-06

Arm Type

Experimental

Arm Description

1,500 unit, 5 days continuous-infusion

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

0 unit, 5 days continuous-infusion

Intervention Type

Drug

Intervention Name(s)

NPB-06

Intervention Description

5 days continuous-infusion

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

5 days continuous-infusion

Primary Outcome Measure Information:

Title

The proportion of patients obtained complete recanalization or partial recanalization of portal vein thrombosis

Description

Contrast enhanced CT assessed by an independent radiologist

Time Frame

an expected average of 2 weeks

Secondary Outcome Measure Information:

Title

The proportion of patients obtained complete recanalization of portal vein thrombosis

Time Frame

an expected average of 2 weeks

Title

Reduction rate of portal vein thrombosis

Time Frame

Up to 3 weeks

Title

Improvement of Child-Pugh score

Time Frame

Up to 5 weeks

Title

Changes in laboratory values (congealing fibrinogenolysis system)

Time Frame

Up to 5 weeks

Title

Adverse events and adverse drug reactions observed between administration and 21 ± 3 days after administration

Time Frame

Up to 5 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Criteria: 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

Facility Information:

City

Chubu

Country

Japan

City

Hokkaido

Country

Japan

City

Kanto

Country

Japan

City

Kyushu

Country

Japan

City

Osaka

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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