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

• Sponsor: Tasly Biopharmaceuticals Co., Ltd. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03108833
• Collaborator: (none)
• Enrollment: 108
• Locations: 18
• Arms: 3
• Actual Duration (Months): 30.4
• Patients Per Site: 6
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acute Pulmonary Embolism	Drug: Recombinant Human Prourokinase; Drug: Alteplase	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 108 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: A Phase IIa Trial to Assess the Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Pulmonary Embolism
• Actual Study Start Date: Jun 6, 2017
• Actual Primary Completion Date: Dec 19, 2019
• Actual Study Completion Date: Dec 19, 2019

Arms and Interventions

Arm	Intervention/Treatment
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

Outcome Measures

Primary Outcome Measures

1. Qanadli CT Score [0 and 48hours after treatment]

   Change of Qanadli Score from baseline by CTPA 48hours after treatment

2. Average pulmonary artery pressure [0,24hours，48hours，7days and 30days after treatment]

   Changes of average pulmonary artery pressure from baseline 24hours，48hours，7days and 30days after treatment

3. Three tricuspid regurgitation velocity [0,24hours，48hours，7days and 30days after treatment]

   Changes of Three tricuspid regurgitation velocity from baseline 24hours，48hours，7days and 30days after treatment

4. RV to LV Diameter Ratio(Ultrasonic echocardiography) [0,24hours，48hours，7days and 30days after treatment]

   Changes of RV to LV Diameter Ratio from baseline 24hours，48hours，7days and 30days after treatment

5. RV to LV Diameter Ratio(CTPA) [0,24hours，48hours，7days and 30days after treatment]

   Changes of RV to LV Diameter Ratio from baseline 24hours，48hours，7days and 30days after treatment

6. Pulmonary systolic pressure [0,24hours，48hours，7days and 30days after treatment]

   Changes of pulmonary systolic pressure from baseline 24hours，48hours，7days and 30days after treatment

7. NT-proBNP [0，48hours and 30days after treatment]

   Changes of NT-proBNP from baseline 48hours and 30days after treatment

8. Major bleeding [From baseline to 30 days]

   The frequency of major bleeding

9. bleeding [From baseline to 30 days]

   The frequency of bleeding

10. Incidence of death from all causes [From baseline to 7 days]

    Incidence of death from all causes

11. Incidence of recurrent pulmonary embolism [From baseline to 7 days]

    Incidence of recurrent pulmonary embolism

12. Incidence of death from all causes [From baseline to 30 days]

    Incidence of death from all causes

13. Incidence of hemodynamic deterioration [From baseline to 7 days]

    Incidence of hemodynamic deterioration

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fuwai Hospital	Beijing	Beijing	China	100037
2	Anzhen Hospital, Capital Medical University	Beijing	Beijing	China
3	Beijing Tongren Hospital,Capital Medical University	Beijing	Beijing	China
4	The Second Affiliated Hospital of Harbin Medical University	Harbin	Heilongjiang	China
5	Henan Provincial People's Hospital	Zhengzhou	Henan	China
6	The First Affiliated Hospital of Zhengzhou University	Zhengzhou	Henan	China
7	Wuhan Asia Heart Hospital	Wuhan	Hubei	China
8	Xiangya Hospital, Central South University	Changsha	Hunan	China
9	Jiangsu Province Hospital	Nanjing	Jiangsu	China
10	Nanjing First Hospital	Nanjing	Jiangsu	China
11	The First Affiliated Hospital of Nanchang University	Nanchang	Jiangxi	China
12	The First Hospital of Jilin University	Changchun	Jilin	China
13	The First Hospital of China Medical University	Shenyang	Liaoning	China
14	General Hospital of Ningxia Medical University	Yinchuan	Ningxia	China
15	The First Affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shanxi	China
16	West China Hospital of Sichuan University	Chengdu	Sichuan	China
17	Tianjin Chest Hospital	Tianjin	Tianjin	China
18	Sir Run Run Shaw Hospital affiliated with the Zhejiang University School of Medicine	Hangzhou	Zhejiang	China

Sponsors and Collaborators

• Tasly Biopharmaceuticals Co., Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tasly Biopharmaceuticals Co., Ltd.
• ClinicalTrials.gov Identifier: NCT03108833
• Other Study ID Numbers: TASLY-B1448
• First Posted: Apr 11, 2017
• Last Update Posted: Mar 18, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• 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
• Additional relevant MeSH terms: Pulmonary Embolism; Embolism; Tissue Plasminogen Activator; Saruplase

Study Results

No Results Posted as of Mar 18, 2021