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Post-marketing Study of Monteplase ("Cleactor") in Patients With Acute Pulmonary Embolism

Primary Purpose

Pulmonary Embolism

Status
Completed
Phase
Phase 4
Locations
Japan
Study Type
Interventional
Intervention
Monteplase
Sponsored by
Eisai Inc.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pulmonary Embolism focused on measuring Acute, pulmonary, embolism, accompanying, hemodynamic, instability

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1) Patients who consent for study participation and submit written informed consent with free will by patient or legally authorized representative.

2) Patients aged between 20 years or above and under 75 years old at the time of obtaining informed consent.

3) Patients with acute pulmonary embolism within 5 days after the onset.

4) Patients with acute pulmonary embolism with hemodynamic instability and fulfill all of the following 4 items:

  1. Confirmed to have thrombi, emboli, or disorders in pulmonary circulation detected by pulmonary angiography or computed tomography.
  2. Confirmed to have any of the following right ventricular overloads by echocardiography:

    i) Dilation of right ventricular cavity or hypokinesis in ventricular wall

    ii) Floating thrombi in pulmonary artery and right heart

    iii) Paradoxical motion in the interventricular septum

    iv) Disparity of tricuspid regurgitation pressure

    v) Enlargement of pulmonary artery

  3. Mean pulmonary arterial pressure (PAP) is 20 mmHg or above
  4. PaO2 is 65 mmHg or below (confirmed by blood gas analysis)

Exclusion Criteria:

  1. Patients with concurrent hemorrhage (e.g., gastrointestinal bleeding, urinary tract bleeding, retroperitoneal bleeding, intracranial bleeding, or hemoptysis).
  2. Patients who underwent intracranial or spinal operation or injury within 2 months prior to study treatment.
  3. Patients with intracranial tumor, arteriovenous malformation, or aneurysm
  4. Patients with hemorrhagic diathesis (e.g., vascular purpura, thrombocytopenia, hemophilia)
  5. Patients with hypertension of systolic blood pressure >=180 mmHg or diastolic pressure >= 110 mmHg.
  6. Patients with a history of cerebrovascular disorder (e.g., cerebral infarction, intracerebral hemorrhage).
  7. Patients with severe hepatic disorder (e.g., cirrhosis, severe hepatitis) or severe renal disorder (e.g., renal failure).
  8. Patients received thrombolytic drug (t-PA or urokinase) within 7 days prior to study treatment.
  9. Patients with pulmonary cardiac arrest (CPA).
  10. Patients with a history of hypersensitivity to monteplase or protein preparations.
  11. Pregnant women, women suspected of being pregnant, women who desire to become pregnant during a period between obtaining informed consent to the final observation, or lactating women.
  12. Patients who are judged to be ineligible for study entry by the investigator or subinvestigator.

Sites / Locations

Outcomes

Primary Outcome Measures

Monteplase antigen levels in plasma; Monteplase activity in plasma; parameters of coagulating and fibrinolytic system (Plasminogen activity, a2-PI, PIC, fibrinogen, D-dimer).

Secondary Outcome Measures

Symptoms and signs of acute pulmonary embolism; pulmonary thrombosis; echocardiography; pulmonary arterial pressure; blood gas; vital signs; laboratory tests (e.g., hematology and blood chemistry); adverse events; concomitant therapies; dosing regimen.

Full Information

First Posted
February 27, 2007
Last Updated
October 16, 2018
Sponsor
Eisai Inc.
Collaborators
Eisai Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT00442234
Brief Title
Post-marketing Study of Monteplase ("Cleactor") in Patients With Acute Pulmonary Embolism
Official Title
Pharmacokinetic/Pharmacodynamic Study of Monteplase ("Cleactor") in Acute Pulmonary Embolism
Study Type
Interventional

2. Study Status

Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
May 1, 2007 (Actual)
Primary Completion Date
April 1, 2008 (Actual)
Study Completion Date
April 1, 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eisai Inc.
Collaborators
Eisai Co., Ltd.

4. Oversight

5. Study Description

Brief Summary
To investigate PK and coagulating and fibrinolytic parameter profiles (PD) at the approved dose (13,750 - 27,500 IU/kg) in patients with acute pulmonary embolism accompanying hemodynamic instability.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pulmonary Embolism
Keywords
Acute, pulmonary, embolism, accompanying, hemodynamic, instability

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Monteplase
Primary Outcome Measure Information:
Title
Monteplase antigen levels in plasma; Monteplase activity in plasma; parameters of coagulating and fibrinolytic system (Plasminogen activity, a2-PI, PIC, fibrinogen, D-dimer).
Secondary Outcome Measure Information:
Title
Symptoms and signs of acute pulmonary embolism; pulmonary thrombosis; echocardiography; pulmonary arterial pressure; blood gas; vital signs; laboratory tests (e.g., hematology and blood chemistry); adverse events; concomitant therapies; dosing regimen.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1) Patients who consent for study participation and submit written informed consent with free will by patient or legally authorized representative. 2) Patients aged between 20 years or above and under 75 years old at the time of obtaining informed consent. 3) Patients with acute pulmonary embolism within 5 days after the onset. 4) Patients with acute pulmonary embolism with hemodynamic instability and fulfill all of the following 4 items: Confirmed to have thrombi, emboli, or disorders in pulmonary circulation detected by pulmonary angiography or computed tomography. Confirmed to have any of the following right ventricular overloads by echocardiography: i) Dilation of right ventricular cavity or hypokinesis in ventricular wall ii) Floating thrombi in pulmonary artery and right heart iii) Paradoxical motion in the interventricular septum iv) Disparity of tricuspid regurgitation pressure v) Enlargement of pulmonary artery Mean pulmonary arterial pressure (PAP) is 20 mmHg or above PaO2 is 65 mmHg or below (confirmed by blood gas analysis) Exclusion Criteria: Patients with concurrent hemorrhage (e.g., gastrointestinal bleeding, urinary tract bleeding, retroperitoneal bleeding, intracranial bleeding, or hemoptysis). Patients who underwent intracranial or spinal operation or injury within 2 months prior to study treatment. Patients with intracranial tumor, arteriovenous malformation, or aneurysm Patients with hemorrhagic diathesis (e.g., vascular purpura, thrombocytopenia, hemophilia) Patients with hypertension of systolic blood pressure >=180 mmHg or diastolic pressure >= 110 mmHg. Patients with a history of cerebrovascular disorder (e.g., cerebral infarction, intracerebral hemorrhage). Patients with severe hepatic disorder (e.g., cirrhosis, severe hepatitis) or severe renal disorder (e.g., renal failure). Patients received thrombolytic drug (t-PA or urokinase) within 7 days prior to study treatment. Patients with pulmonary cardiac arrest (CPA). Patients with a history of hypersensitivity to monteplase or protein preparations. Pregnant women, women suspected of being pregnant, women who desire to become pregnant during a period between obtaining informed consent to the final observation, or lactating women. Patients who are judged to be ineligible for study entry by the investigator or subinvestigator.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takashi Musha
Organizational Affiliation
Department Marketed Product Research, Clinical Research Center
Official's Role
Study Director
Facility Information:
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
245-8575
Country
Japan
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8603
Country
Japan

12. IPD Sharing Statement

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Post-marketing Study of Monteplase ("Cleactor") in Patients With Acute Pulmonary Embolism

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