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

Tasly Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Acute Pulmonary Embolism

Treatments: Drug: Recombinant Human Prourokinase; Drug: Alteplase

Study type: Interventional

Funder types: Industry

Identifiers

NCT03108833

TASLY-B1448

Details and patient eligibility

About

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

Enrollment: 108 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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108 participants in 3 patient groups

Low Dose Experimental Group

Experimental group

Description:

Recombinant Human Prourokinase:40mg

Treatment:

Drug: Recombinant Human Prourokinase

High Dose Experimental Group

Experimental group

Description:

Recombinant Human Prourokinase:50mg

Treatment:

Drug: Recombinant Human Prourokinase

Active Comparator Controlled Group

Active Comparator group

Description:

Alteplase:100mg if weight\>=65kg, 1.5mg/kg if weight\<65kg

Treatment:

Drug: Alteplase