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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00442234
Recruitment Status : Completed
First Posted : March 1, 2007
Last Update Posted : October 18, 2018
Sponsor:
Collaborator:
Eisai Co., Ltd.
Information provided by (Responsible Party):
Eisai Inc.

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.

Condition or disease Intervention/treatment Phase
Pulmonary Embolism Drug: Monteplase Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pharmacokinetic/Pharmacodynamic Study of Monteplase ("Cleactor") in Acute Pulmonary Embolism
Actual Study Start Date : May 1, 2007
Actual Primary Completion Date : April 1, 2008
Actual Study Completion Date : April 1, 2008

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. 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 :
  1. 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.


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00442234


Locations
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Japan
Yokohama, Kanagawa, Japan, 245-8575
Bunkyo-ku, Tokyo, Japan, 113-8603
Sponsors and Collaborators
Eisai Inc.
Eisai Co., Ltd.
Investigators
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Study Director: Takashi Musha Department Marketed Product Research, Clinical Research Center

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Responsible Party: Eisai Inc.
ClinicalTrials.gov Identifier: NCT00442234    
Other Study ID Numbers: E6010-J081-591
First Posted: March 1, 2007    Key Record Dates
Last Update Posted: October 18, 2018
Last Verified: January 2010
Keywords provided by Eisai Inc.:
Acute
pulmonary
embolism
accompanying
hemodynamic
instability
Additional relevant MeSH terms:
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Pulmonary Embolism
Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases
Monteplase
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action