Pulmonary EmbolismPhase 4NCT00442234
Post-marketing Study of Monteplase ("Cleactor") in Patients With Acute Pulmonary Embolism
A Phase 4 study testing Monteplase in people with Pulmonary Embolism, run by Eisai Inc. at 2 sites in Japan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Pulmonary Embolism
- What is being tested?
- Monteplase
- How many people
- 5 participants
- Where
- 2 sitesJapan
- Study dates
- 1 May 2007to 1 Apr 2008
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
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- Dilation of right ventricular cavity or hypokinesis in ventricular wall
- Floating thrombi in pulmonary artery and right heart
- Paradoxical motion in the interventricular septum
- Disparity of tricuspid regurgitation pressure
- 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)
Who cannot join
- 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).
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- 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.
Trial locations and contacts
2 sites in 1 country.
Japan2 sites
Study site
Bunkyo-ku, Tokyo, 113-8603
Study site
Yokohama, Kanagawa, 245-8575
About this study
Official title: Pharmacokinetic/Pharmacodynamic Study of Monteplase ("Cleactor") in Acute Pulmonary Embolism
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
- Being tested
- Monteplase
- Keywords
- Acute, pulmonary, embolism, accompanying, hemodynamic, instability
- Medical subject headings
- Pulmonary Embolism, Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MonteplaseDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2007 (estimated)
- Study start1 May 2007
- Primary completion1 Apr 2008
- Study completion1 Apr 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary EmbolismStudies of the same condition, open and under way.
- More trials run by Eisai Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eisai Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eisai Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Takashi Musha, Study director, Department Marketed Product Research, Clinical Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00442234
- Sponsor's protocol ID
- E6010-J081-591
- Status last verified
- Jan 2010
- First submitted
- 27 Feb 2007
- Last updated
- 18 Oct 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetic/Pharmacodynamic Study of Monteplase ("Cleactor") in Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT00442234
- Acronym / sponsor ID
- E6010-J081-591
- Conditions
- Pulmonary Embolism
- Keywords
- Acute, pulmonary, embolism, accompanying, hemodynamic, instability
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Eisai Inc.Industry (pharma, biotech, devices)
- Collaborators
- Eisai Co., Ltd.
- Study start
- 1 May 2007 (actual)
- Primary completion
- 1 Apr 2008 (actual)
- Study completion
- 1 Apr 2008 (actual)
- First posted
- 1 Mar 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Monteplase | Drug | – |
Primary outcome
Monteplase antigen levels in plasma; Monteplase activity in plasma; parameters of coagulating and fibrinolytic system (Plasminogen activity, a2-PI, PIC, fibrinogen, D-dimer).
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Takashi Musha study director
Department Marketed Product Research, Clinical Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Monteplase in people with Pulmonary Embolism, run by Eisai Inc. at 2 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Monteplase antigen levels in plasma; Monteplase activity in plasma; parameters of coagulating and fibrinolytic system (Plasminogen activity, a2-PI, PIC, fibrinogen, D-dimer).. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2018.