A Trial in Recombinant Human Prourokinase to Treat Acute Pulmonary Embolism (ERUPTE)

March 16, 2021 updated by: Tasly Biopharmaceuticals Co., Ltd.

A Phase IIa Trial to Assess the Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Pulmonary Embolism

This trial is being conducted to assess the efficacy and safety of recombinant Human Prourokinase in the acute pulmonary embolism.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
108

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100037
        • Fuwai Hospital
      • Beijing, Beijing, China
        • Anzhen Hospital, Capital Medical University
      • Beijing, Beijing, China
        • Beijing Tongren Hospital,Capital Medical University
    • Heilongjiang
      • Harbin, Heilongjiang, China
        • The Second Affiliated Hospital of Harbin Medical University
    • Henan
      • Zhengzhou, Henan, China
        • the First Affiliated Hospital of Zhengzhou University
      • Zhengzhou, Henan, China
        • Henan Provincial People's Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Wuhan Asia Heart Hospital
    • Hunan
      • Changsha, Hunan, China
        • Xiangya Hospital, Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China
        • Jiangsu Province Hospital
      • Nanjing, Jiangsu, China
        • Nanjing First Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China
        • The First Affiliated Hospital of Nanchang University
    • Jilin
      • Changchun, Jilin, China
        • The First Hospital of Jilin University
    • Liaoning
      • Shenyang, Liaoning, China
        • The First Hospital of China Medical University
    • Ningxia
      • Yinchuan, Ningxia, China
        • General Hospital of Ningxia Medical University
    • Shanxi
      • Xi'an, Shanxi, China
        • The First Affiliated Hospital Of Xi'an Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, China
        • West China Hospital of Sichuan University
    • Tianjin
      • Tianjin, Tianjin, China
        • Tianjin Chest Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • Sir Run Run Shaw Hospital affiliated with the Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Aged 18-75 years（Include the critical value）AND
  2. High-risk PE or medium high-risk PE AND
  3. PE symptom duration ≤14 days AND
  4. PLT≥100×10^9/L，ALT and AST≤2.5ULN，TBIL<ULN，Cr within the normal range AND
  5. Informed consent can be obtained from subject or Legally Authorized Representative

Exclusion Criteria:

  1. Hemorrhagic or unexplained stroke history
  2. Ischemic stroke or transient ischemic attack (TIA) within 6 months
  3. The existence of the central nervous system injury or tumor
  4. Severe trauma，major surgery or head injury within 3 weeks
  5. Active bleeding within 1 month
  6. Clinician deems high-risk for bleeding
  7. Using anticoagulants (after a washout period can be randomized)
  8. Pregnancy or delivery within 1 week
  9. Vascular puncture which can not be oppressed
  10. Cardiopulmonary resuscitation within 10 days
  11. Systolic blood pressure above 180 mmHg or diastolic blood pressure above 100mmHg
  12. Severe liver dysfunction
  13. Infective endocarditis
  14. Arterial aneurysm or arteriovenous malformation or suspected aortic dissection
  15. left atrial thrombus
  16. Neurosurgery or eye surgery within 1 month
  17. Hemorrhagic diabetic retinopathy
  18. Serious cardiac insufficiency
  19. ventricular arrhythmias
  20. Known allergic to prourokinase，urokinase，recombinant tissue-type plasminogen activator，contrast agent or any drug in the trial
  21. Do not allow for 30 days' study
  22. Any disease or condition is not suitable for intravenous thrombolysis
  23. Lactating women or plan to pregnant women during the trial，or don't want to during the study period using effective contraception or abstinence of male and female patients with possibility of fertility
  24. Clinician thinks patient doesn't fit to participate in the test of other diseases or conditions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: Low Dose Experimental Group
Recombinant Human Prourokinase:40mg
Drug: Recombinant Human Prourokinase
The drug is used for intravenous thrombolysis therapy
Other Names:
  • rhPro-UK
EXPERIMENTAL: High Dose Experimental Group
Recombinant Human Prourokinase:50mg
Drug: Recombinant Human Prourokinase
The drug is used for intravenous thrombolysis therapy
Other Names:
  • rhPro-UK
ACTIVE_COMPARATOR: Active Comparator Controlled Group
Alteplase:100mg if weight>=65kg, 1.5mg/kg if weight<65kg
Drug: Alteplase
The drug is used for intravenous thrombolysis therapy
Other Names:
  • Actilyse
  • rtPA

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Qanadli CT Score
Time Frame: 0 and 48hours after treatment
Change of Qanadli Score from baseline by CTPA 48hours after treatment
0 and 48hours after treatment
Average pulmonary artery pressure
Time Frame: 0,24hours，48hours，7days and 30days after treatment
Changes of average pulmonary artery pressure from baseline 24hours，48hours，7days and 30days after treatment
0,24hours，48hours，7days and 30days after treatment
Three tricuspid regurgitation velocity
Time Frame: 0,24hours，48hours，7days and 30days after treatment
Changes of Three tricuspid regurgitation velocity from baseline 24hours，48hours，7days and 30days after treatment
0,24hours，48hours，7days and 30days after treatment
RV to LV Diameter Ratio(Ultrasonic echocardiography)
Time Frame: 0,24hours，48hours，7days and 30days after treatment
Changes of RV to LV Diameter Ratio from baseline 24hours，48hours，7days and 30days after treatment
0,24hours，48hours，7days and 30days after treatment
RV to LV Diameter Ratio(CTPA)
Time Frame: 0,24hours，48hours，7days and 30days after treatment
Changes of RV to LV Diameter Ratio from baseline 24hours，48hours，7days and 30days after treatment
0,24hours，48hours，7days and 30days after treatment
Pulmonary systolic pressure
Time Frame: 0,24hours，48hours，7days and 30days after treatment
Changes of pulmonary systolic pressure from baseline 24hours，48hours，7days and 30days after treatment
0,24hours，48hours，7days and 30days after treatment
NT-proBNP
Time Frame: 0，48hours and 30days after treatment
Changes of NT-proBNP from baseline 48hours and 30days after treatment
0，48hours and 30days after treatment
Major bleeding
Time Frame: From baseline to 30 days
The frequency of major bleeding
From baseline to 30 days
bleeding
Time Frame: From baseline to 30 days
The frequency of bleeding
From baseline to 30 days
Incidence of death from all causes
Time Frame: From baseline to 7 days
Incidence of death from all causes
From baseline to 7 days
Incidence of recurrent pulmonary embolism
Time Frame: From baseline to 7 days
Incidence of recurrent pulmonary embolism
From baseline to 7 days
Incidence of death from all causes
Time Frame: From baseline to 30 days
Incidence of death from all causes
From baseline to 30 days
Incidence of hemodynamic deterioration
Time Frame: From baseline to 7 days
Incidence of hemodynamic deterioration
From baseline to 7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Tasly Biopharmaceuticals Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 6, 2017

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 19, 2019

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 19, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 5, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 11, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 18, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 16, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TASLY-B1448

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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