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

• ClinicalTrials.gov Identifier: NCT00442234
• Recruitment Status: Completed
• First Posted: March 1, 2007
• Last Update Posted: October 18, 2018
• Sponsor: Eisai Inc.
• Collaborator: Eisai Co., Ltd.
• Information provided by (Responsible Party): Eisai Inc.

Tracking Information

• First Submitted Date: February 27, 2007
• First Posted Date: March 1, 2007
• Last Update Posted Date: October 18, 2018
• Actual Study Start Date: May 1, 2007
• Actual Primary Completion Date: April 1, 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: February 28, 2007): Monteplase antigen levels in plasma; Monteplase activity in plasma; parameters of coagulating and fibrinolytic system (Plasminogen activity, a2-PI, PIC, fibrinogen, D-dimer).
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: February 28, 2007): 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.
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 4
• Study Design: Allocation: Non-Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pulmonary Embolism
• Intervention: Drug: Monteplase
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 16, 2018): 5
• Original Enrollment (submitted: February 28, 2007): 4
• Actual Study Completion Date: April 1, 2008
• Actual Primary Completion Date: April 1, 2008 (Final data collection date for primary outcome measure)

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:

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 20 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Japan

Administrative Information

• NCT Number: NCT00442234
• Other Study ID Numbers: E6010-J081-591
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Eisai Inc.
• Original Responsible Party: Not Provided
• Current Study Sponsor: Eisai Inc.
• Original Study Sponsor: Eisai Limited
• Collaborators: Eisai Co., Ltd.

Investigators

• Study Director: Takashi Musha; Department Marketed Product Research, Clinical Research Center

• PRS Account: Eisai Inc.
• Verification Date: January 2010