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

NCT00442234 | Completed Phase 4

• 1 other identifier: E6010-J081-591
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Embolism

Keywords

Acute; pulmonary; embolism; accompanying; hemodynamic; instability

Outcome Measures

Primary Outcomes (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 Outcomes (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.

Interventions

Monteplase DRUG

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \) Patients who consent for study participation and submit written informed consent with free will by patient or legally authorized representative.
• \) Patients aged between 20 years or above and under 75 years old at the time of obtaining informed consent.
• \) Patients with acute pulmonary embolism within 5 days after the onset.
• \) 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Eisai Inc.: lead
• Eisai Co., Ltd.: collaborator

Study Sites (2)

Unknown Facility

Yokohama, Kanagawa, 245-8575, Japan

Location

Unknown Facility

Bunkyo-ku, Tokyo, 113-8603, Japan

Location

MeSH Terms

Conditions

Pulmonary Embolism; Embolism

Interventions

monteplase

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Takashi Musha

  Department Marketed Product Research, Clinical Research Center

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2007
• First Posted: March 1, 2007
• Study Start: May 1, 2007
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: October 18, 2018

Record last verified: 2010-01

Locations

JP (2)