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

NCT02250391 | Completed Phase 3

• 1 other identifier: NPB-06-04/C-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 5

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.

Conditions

Portal Vein Thrombosis

Outcome Measures

Primary Outcomes (1)

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

  Contrast enhanced CT assessed by an independent radiologist

  an expected average of 2 weeks

Secondary Outcomes (5)

• 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

Study Arms (2)

NPB-06

EXPERIMENTAL

1,500 unit, 5 days continuous-infusion

Drug: NPB-06

Placebo

PLACEBO COMPARATOR

0 unit, 5 days continuous-infusion

Drug: Placebo

Interventions

NPB-06 DRUG

5 days continuous-infusion

NPB-06

Placebo DRUG

5 days continuous-infusion

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nihon Pharmaceutical Co., Ltd: lead

Study Sites (5)

Unknown Facility

Chūbu, Japan

Location

Unknown Facility

Hokkaido, Japan

Location

Unknown Facility

Kanto, Japan

Location

Unknown Facility

Kyushu, Japan

Location

Unknown Facility

Osaka, Japan

Location

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2014
• First Posted: September 26, 2014
• Study Start: September 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 9, 2016

Record last verified: 2016-09

Locations

JP (5)