A Trial in Recombinant Human Prourokinase to Treat Acute Pulmonary Embolism

Acute Pulmonary Embolism Clinical Trial

— ERUPTE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03108833
• Other study ID #: TASLY-B1448
• Status: Completed
• Phase: Phase 2
• Start date: June 6, 2017
• Est. completion date: December 19, 2019

Study information

• Verified date: March 2021
• Source: Tasly Biopharmaceuticals Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: December 19, 2019
• Est. primary completion date: December 19, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Pulmonary Embolism
• Embolism
• Pulmonary Embolism

Intervention

Drug:
• Recombinant Human Prourokinase
The drug is used for intravenous thrombolysis therapy
• Alteplase
The drug is used for intravenous thrombolysis therapy

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Tasly Biopharmaceuticals Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Qanadli CT Score	Change of Qanadli Score from baseline by CTPA 48hours after treatment	0 and 48hours after treatment
Primary	Average pulmonary artery pressure	Changes of average pulmonary artery pressure from baseline 24hours,48hours,7days and 30days after treatment	0,24hours,48hours,7days and 30days after treatment
Primary	Three tricuspid regurgitation velocity	Changes of Three tricuspid regurgitation velocity from baseline 24hours,48hours,7days and 30days after treatment	0,24hours,48hours,7days and 30days after treatment
Primary	RV to LV Diameter Ratio(Ultrasonic echocardiography)	Changes of RV to LV Diameter Ratio from baseline 24hours,48hours,7days and 30days after treatment	0,24hours,48hours,7days and 30days after treatment
Primary	RV to LV Diameter Ratio(CTPA)	Changes of RV to LV Diameter Ratio from baseline 24hours,48hours,7days and 30days after treatment	0,24hours,48hours,7days and 30days after treatment
Primary	Pulmonary systolic pressure	Changes of pulmonary systolic pressure from baseline 24hours,48hours,7days and 30days after treatment	0,24hours,48hours,7days and 30days after treatment
Primary	NT-proBNP	Changes of NT-proBNP from baseline 48hours and 30days after treatment	0,48hours and 30days after treatment
Primary	Major bleeding	The frequency of major bleeding	From baseline to 30 days
Primary	bleeding	The frequency of bleeding	From baseline to 30 days
Primary	Incidence of death from all causes	Incidence of death from all causes	From baseline to 7 days
Primary	Incidence of recurrent pulmonary embolism	Incidence of recurrent pulmonary embolism	From baseline to 7 days
Primary	Incidence of death from all causes	Incidence of death from all causes	From baseline to 30 days
Primary	Incidence of hemodynamic deterioration	Incidence of hemodynamic deterioration	From baseline to 7 days