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Completed

NCT Number: NCT02250391

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

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.

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Key information

Conditions

Portal Vein Thrombosis

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Chūbu, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

NPB-06

Drug

5 days continuous-infusion

Placebo

Drug

5 days continuous-infusion

Primary outcomes

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

    Time frame: an expected average of 2 weeks

    Contrast enhanced CT assessed by an independent radiologist

Secondary outcomes

  1. The proportion of patients obtained complete recanalization of portal vein thrombosis

    Time frame: an expected average of 2 weeks

  2. Reduction rate of portal vein thrombosis

    Time frame: Up to 3 weeks

  3. Improvement of Child-Pugh score

    Time frame: Up to 5 weeks

  4. Changes in laboratory values (congealing fibrinogenolysis system)

    Time frame: Up to 5 weeks

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

    Time frame: Up to 5 weeks

Sponsors and collaborators

Lead sponsor

Nihon Pharmaceutical Co., Ltd

Industry

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Sep 26, 2014
Registry last updated
Sep 9, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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