Back to resultsA Trial in Recombinant Human Prourokinase to Treat Acute Pulmonary Embolism (ERUPTE)
Primary Purpose
Acute Pulmonary Embolism
Status
Completed
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Recombinant Human Prourokinase
Alteplase
Sponsored by
About this trial
This is an interventional treatment trial for Acute Pulmonary Embolism
Eligibility Criteria
Inclusion Criteria:
- Aged 18-75 years（Include the critical value）AND
- High-risk PE or medium high-risk PE AND
- PE symptom duration ≤14 days AND
- PLT≥100×10^9/L，ALT and AST≤2.5ULN，TBIL<ULN，Cr within the normal range AND
- Informed consent can be obtained from subject or Legally Authorized Representative
Exclusion Criteria:
- Hemorrhagic or unexplained stroke history
- Ischemic stroke or transient ischemic attack (TIA) within 6 months
- The existence of the central nervous system injury or tumor
- Severe trauma，major surgery or head injury within 3 weeks
- Active bleeding within 1 month
- Clinician deems high-risk for bleeding
- Using anticoagulants (after a washout period can be randomized)
- Pregnancy or delivery within 1 week
- Vascular puncture which can not be oppressed
- Cardiopulmonary resuscitation within 10 days
- Systolic blood pressure above 180 mmHg or diastolic blood pressure above 100mmHg
- Severe liver dysfunction
- Infective endocarditis
- Arterial aneurysm or arteriovenous malformation or suspected aortic dissection
- left atrial thrombus
- Neurosurgery or eye surgery within 1 month
- Hemorrhagic diabetic retinopathy
- Serious cardiac insufficiency
- ventricular arrhythmias
- Known allergic to prourokinase，urokinase，recombinant tissue-type plasminogen activator，contrast agent or any drug in the trial
- Do not allow for 30 days' study
- Any disease or condition is not suitable for intravenous thrombolysis
- 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
- Clinician thinks patient doesn't fit to participate in the test of other diseases or conditions
Sites / Locations
- Fuwai Hospital
- Anzhen Hospital, Capital Medical University
- Beijing Tongren Hospital,Capital Medical University
- The Second Affiliated Hospital of Harbin Medical University
- Henan Provincial People's Hospital
- The First Affiliated Hospital of Zhengzhou University
- Wuhan Asia Heart Hospital
- Xiangya Hospital, Central South University
- Jiangsu Province Hospital
- Nanjing First Hospital
- The First Affiliated Hospital of Nanchang University
- The First Hospital of Jilin University
- The First Hospital of China Medical University
- General Hospital of Ningxia Medical University
- The First Affiliated Hospital of Xi'an Jiaotong University
- West China Hospital of Sichuan University
- Tianjin Chest Hospital
- Sir Run Run Shaw Hospital affiliated with the Zhejiang University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Low Dose Experimental Group
High Dose Experimental Group
Active Comparator Controlled Group
Arm Description
Recombinant Human Prourokinase:40mg
Recombinant Human Prourokinase:50mg
Alteplase:100mg if weight>=65kg, 1.5mg/kg if weight<65kg
Outcomes
Primary Outcome Measures
Qanadli CT Score
Change of Qanadli Score from baseline by CTPA 48hours after treatment
Average pulmonary artery pressure
Changes of average pulmonary artery pressure from baseline 24hours，48hours，7days and 30days after treatment
Three tricuspid regurgitation velocity
Changes of Three tricuspid regurgitation velocity from baseline 24hours，48hours，7days and 30days after treatment
RV to LV Diameter Ratio(Ultrasonic echocardiography)
Changes of RV to LV Diameter Ratio from baseline 24hours，48hours，7days and 30days after treatment
RV to LV Diameter Ratio(CTPA)
Changes of RV to LV Diameter Ratio from baseline 24hours，48hours，7days and 30days after treatment
Pulmonary systolic pressure
Changes of pulmonary systolic pressure from baseline 24hours，48hours，7days and 30days after treatment
NT-proBNP
Changes of NT-proBNP from baseline 48hours and 30days after treatment
Major bleeding
The frequency of major bleeding
bleeding
The frequency of bleeding
Incidence of death from all causes
Incidence of death from all causes
Incidence of recurrent pulmonary embolism
Incidence of recurrent pulmonary embolism
Incidence of death from all causes
Incidence of death from all causes
Incidence of hemodynamic deterioration
Incidence of hemodynamic deterioration
Secondary Outcome Measures
Full Information
NCT ID
NCT03108833
First Posted
April 5, 2017
Last Updated
March 16, 2021
Sponsor
Tasly Biopharmaceuticals Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03108833
Brief Title
A Trial in Recombinant Human Prourokinase to Treat Acute Pulmonary Embolism
Acronym
ERUPTE
Official Title
A Phase IIa Trial to Assess the Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Pulmonary Embolism
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
June 6, 2017 (Actual)
Primary Completion Date
December 19, 2019 (Actual)
Study Completion Date
December 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tasly Biopharmaceuticals Co., Ltd.
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
This trial is being conducted to assess the efficacy and safety of recombinant Human Prourokinase in the acute pulmonary embolism.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Pulmonary Embolism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
108 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Dose Experimental Group
Arm Type
Experimental
Arm Description
Recombinant Human Prourokinase:40mg
Arm Title
High Dose Experimental Group
Arm Type
Experimental
Arm Description
Recombinant Human Prourokinase:50mg
Arm Title
Active Comparator Controlled Group
Arm Type
Active Comparator
Arm Description
Alteplase:100mg if weight>=65kg, 1.5mg/kg if weight<65kg
Intervention Type
Drug
Intervention Name(s)
Recombinant Human Prourokinase
Other Intervention Name(s)
rhPro-UK
Intervention Description
The drug is used for intravenous thrombolysis therapy
Intervention Type
Drug
Intervention Name(s)
Alteplase
Other Intervention Name(s)
Actilyse, rtPA
Intervention Description
The drug is used for intravenous thrombolysis therapy
Primary Outcome Measure Information:
Title
Qanadli CT Score
Description
Change of Qanadli Score from baseline by CTPA 48hours after treatment
Time Frame
0 and 48hours after treatment
Title
Average pulmonary artery pressure
Description
Changes of average pulmonary artery pressure from baseline 24hours，48hours，7days and 30days after treatment
Time Frame
0,24hours，48hours，7days and 30days after treatment
Title
Three tricuspid regurgitation velocity
Description
Changes of Three tricuspid regurgitation velocity from baseline 24hours，48hours，7days and 30days after treatment
Time Frame
0,24hours，48hours，7days and 30days after treatment
Title
RV to LV Diameter Ratio(Ultrasonic echocardiography)
Description
Changes of RV to LV Diameter Ratio from baseline 24hours，48hours，7days and 30days after treatment
Time Frame
0,24hours，48hours，7days and 30days after treatment
Title
RV to LV Diameter Ratio(CTPA)
Description
Changes of RV to LV Diameter Ratio from baseline 24hours，48hours，7days and 30days after treatment
Time Frame
0,24hours，48hours，7days and 30days after treatment
Title
Pulmonary systolic pressure
Description
Changes of pulmonary systolic pressure from baseline 24hours，48hours，7days and 30days after treatment
Time Frame
0,24hours，48hours，7days and 30days after treatment
Title
NT-proBNP
Description
Changes of NT-proBNP from baseline 48hours and 30days after treatment
Time Frame
0，48hours and 30days after treatment
Title
Major bleeding
Description
The frequency of major bleeding
Time Frame
From baseline to 30 days
Title
bleeding
Description
The frequency of bleeding
Time Frame
From baseline to 30 days
Title
Incidence of death from all causes
Description
Incidence of death from all causes
Time Frame
From baseline to 7 days
Title
Incidence of recurrent pulmonary embolism
Description
Incidence of recurrent pulmonary embolism
Time Frame
From baseline to 7 days
Title
Incidence of death from all causes
Description
Incidence of death from all causes
Time Frame
From baseline to 30 days
Title
Incidence of hemodynamic deterioration
Description
Incidence of hemodynamic deterioration
Time Frame
From baseline to 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 18-75 years（Include the critical value）AND
High-risk PE or medium high-risk PE AND
PE symptom duration ≤14 days AND
PLT≥100×10^9/L，ALT and AST≤2.5ULN，TBIL<ULN，Cr within the normal range AND
Informed consent can be obtained from subject or Legally Authorized Representative
Exclusion Criteria:
Hemorrhagic or unexplained stroke history
Ischemic stroke or transient ischemic attack (TIA) within 6 months
The existence of the central nervous system injury or tumor
Severe trauma，major surgery or head injury within 3 weeks
Active bleeding within 1 month
Clinician deems high-risk for bleeding
Using anticoagulants (after a washout period can be randomized)
Pregnancy or delivery within 1 week
Vascular puncture which can not be oppressed
Cardiopulmonary resuscitation within 10 days
Systolic blood pressure above 180 mmHg or diastolic blood pressure above 100mmHg
Severe liver dysfunction
Infective endocarditis
Arterial aneurysm or arteriovenous malformation or suspected aortic dissection
left atrial thrombus
Neurosurgery or eye surgery within 1 month
Hemorrhagic diabetic retinopathy
Serious cardiac insufficiency
ventricular arrhythmias
Known allergic to prourokinase，urokinase，recombinant tissue-type plasminogen activator，contrast agent or any drug in the trial
Do not allow for 30 days' study
Any disease or condition is not suitable for intravenous thrombolysis
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
Clinician thinks patient doesn't fit to participate in the test of other diseases or conditions
Facility Information:
Facility Name
Fuwai Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100037
Country
China
Facility Name
Anzhen Hospital, Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
Beijing Tongren Hospital,Capital Medical University
City
Beijing
State/Province
Beijing
Country
China
Facility Name
The Second Affiliated Hospital of Harbin Medical University
City
Harbin
State/Province
Heilongjiang
Country
China
Facility Name
Henan Provincial People's Hospital
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
The First Affiliated Hospital of Zhengzhou University
City
Zhengzhou
State/Province
Henan
Country
China
Facility Name
Wuhan Asia Heart Hospital
City
Wuhan
State/Province
Hubei
Country
China
Facility Name
Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
Country
China
Facility Name
Jiangsu Province Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
Country
China
Facility Name
The First Affiliated Hospital of Nanchang University
City
Nanchang
State/Province
Jiangxi
Country
China
Facility Name
The First Hospital of Jilin University
City
Changchun
State/Province
Jilin
Country
China
Facility Name
The First Hospital of China Medical University
City
Shenyang
State/Province
Liaoning
Country
China
Facility Name
General Hospital of Ningxia Medical University
City
Yinchuan
State/Province
Ningxia
Country
China
Facility Name
The First Affiliated Hospital of Xi'an Jiaotong University
City
Xi'an
State/Province
Shanxi
Country
China
Facility Name
West China Hospital of Sichuan University
City
Chengdu
State/Province
Sichuan
Country
China
Facility Name
Tianjin Chest Hospital
City
Tianjin
State/Province
Tianjin
Country
China
Facility Name
Sir Run Run Shaw Hospital affiliated with the Zhejiang University School of Medicine
City
Hangzhou
State/Province
Zhejiang
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Trial in Recombinant Human Prourokinase to Treat Acute Pulmonary Embolism
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