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

This study has been completed.
Sponsor:
Collaborator:
Eisai Limited
Information provided by:
Eisai Inc.
ClinicalTrials.gov Identifier:
NCT00442234
First received: February 27, 2007
Last updated: January 27, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Pulmonary Embolism
Drug: Monteplase
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Pharmacokinetic/Pharmacodynamic Study of Monteplase ("Cleactor") in Acute Pulmonary Embolism

Resource links provided by NLM:


Further study details as provided by Eisai Inc.:

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). [ Designated as safety issue: No ]

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. [ Designated as safety issue: Yes ]

Estimated Enrollment: 4
Study Start Date: May 2007
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
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) Loss of inrespiratory changes of inferior vena cava in diameter

    vi) 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00442234

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

No publications provided

ClinicalTrials.gov Identifier: NCT00442234     History of Changes
Other Study ID Numbers: E6010-J081-591
Study First Received: February 27, 2007
Last Updated: January 27, 2010
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Eisai Inc.:
Acute
pulmonary
embolism
accompanying
hemodynamic
instability

Additional relevant MeSH terms:
Embolism
Pulmonary Embolism
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 21, 2014