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Completed

NCT Number: NCT03108833

A Trial in Recombinant Human Prourokinase to Treat Acute Pulmonary Embolism

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

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Key information

Conditions

Acute Pulmonary Embolism

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Anzhen Hospital, Capital Medical University, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Recombinant Human Prourokinase

Drug

The drug is used for intravenous thrombolysis therapy

Other names: rhPro-UK

alteplase

Drug

The drug is used for intravenous thrombolysis therapy

Other names: Actilyse, rtPA

Primary outcomes

  1. Qanadli CT Score

    Time frame: 0 and 48hours after treatment

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

  2. Average pulmonary artery pressure

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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

    Time frame: 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

    Time frame: 0，48hours and 30days after treatment

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

  8. Major bleeding

    Time frame: From baseline to 30 days

    The frequency of major bleeding

  9. bleeding

    Time frame: From baseline to 30 days

    The frequency of bleeding

  10. Incidence of death from all causes

    Time frame: From baseline to 7 days

    Incidence of death from all causes

  11. Incidence of recurrent pulmonary embolism

    Time frame: From baseline to 7 days

    Incidence of recurrent pulmonary embolism

  12. Incidence of death from all causes

    Time frame: From baseline to 30 days

    Incidence of death from all causes

  13. Incidence of hemodynamic deterioration

    Time frame: From baseline to 7 days

    Incidence of hemodynamic deterioration

Sponsors and collaborators

Lead sponsor

Tasly Biopharmaceuticals Co., Ltd.

Industry

Registry information

Official study title

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

Acronym: ERUPTE

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 11, 2017
Registry last updated
Mar 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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