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

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: Completed
• Conditions: Acute Pulmonary Embolism
• Intervention / Treatment: Drug: Recombinant Human Prourokinase; Drug: Alteplase

• Study Type: Interventional
• Enrollment (Actual): 108
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qanadli CT Score	Change of Qanadli Score from baseline by CTPA 48hours after treatment	0 and 48hours after treatment
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
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
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
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
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
NT-proBNP	Changes of NT-proBNP from baseline 48hours and 30days after treatment	0，48hours and 30days after treatment
Major bleeding	The frequency of major bleeding	From baseline to 30 days
bleeding	The frequency of bleeding	From baseline to 30 days
Incidence of death from all causes	Incidence of death from all causes	From baseline to 7 days
Incidence of recurrent pulmonary embolism	Incidence of recurrent pulmonary embolism	From baseline to 7 days
Incidence of death from all causes	Incidence of death from all causes	From baseline to 30 days
Incidence of hemodynamic deterioration	Incidence of hemodynamic deterioration	From baseline to 7 days

Collaborators and Investigators

• Sponsor: Tasly Biopharmaceuticals Co., Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 6, 2017
• Primary Completion (ACTUAL): December 19, 2019
• Study Completion (ACTUAL): December 19, 2019

Study Registration Dates

• First Submitted: April 5, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (ACTUAL): April 11, 2017

Study Record Updates

• Last Update Posted (ACTUAL): March 18, 2021
• Last Update Submitted That Met QC Criteria: March 16, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Embolism; Pulmonary Embolism; Molecular Mechanisms of Pharmacological Action; Fibrinolytic Agents; Fibrin Modulating Agents; Tissue Plasminogen Activator; Saruplase
• Other Study ID 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