Acute Pulmonary EmbolismPhase 2ERUPTENCT03108833
A Trial in Recombinant Human Prourokinase to Treat Acute Pulmonary Embolism
A Phase 2 study testing Recombinant Human Prourokinase and Alteplase in people with Acute Pulmonary Embolism, run by Tasly Biopharmaceuticals Co., Ltd. at 18 sites in China.
Trial summary
This trial is being conducted to assess the efficacy and safety of recombinant Human Prourokinase in the acute pulmonary embolism. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Pulmonary Embolism
- What is being tested?
- Recombinant Human Prourokinase and Alteplase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 108 participants
- Where
- 18 sitesChina
- Study dates
- 6 Jun 2017to 19 Dec 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
China18 sites
Fuwai Hospital
Beijing, Beijing Municipality, 100037
Anzhen Hospital, Capital Medical University
Beijing, Beijing Municipality
Beijing Tongren Hospital,Capital Medical University
Beijing, Beijing Municipality
The First Hospital of Jilin University
Changchun, Jilin
Xiangya Hospital, Central South University
Changsha, Hunan
West China Hospital of Sichuan University
Chengdu, Sichuan
Sir Run Run Shaw Hospital affiliated with the Zhejiang University School of Medicine
Hangzhou, Zhejiang
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi
Jiangsu Province Hospital
Nanjing, Jiangsu
Nanjing First Hospital
Nanjing, Jiangsu
The First Hospital of China Medical University
Shenyang, Liaoning
Tianjin Chest Hospital
Tianjin, Tianjin Municipality
Wuhan Asia Heart Hospital
Wuhan, Hubei
The First Affiliated Hospital of Xi'an Jiaotong University
Xi’an, Shanxi
General Hospital of Ningxia Medical University
Yinchuan, Ningxia
Henan Provincial People's Hospital
Zhengzhou, Henan
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan
About this study
Official title: 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.
- Conditions
- Acute Pulmonary Embolism
- Being tested
- Recombinant Human Prourokinase, Alteplase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Human ProurokinaseDrug
Also called rhPro-UK
The drug is used for intravenous thrombolysis therapy
AlteplaseDrug
Also called Actilyse, rtPA
The drug is used for intravenous thrombolysis therapy
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Experimental Group | Experimental | Recombinant Human Prourokinase:40mg Receives: Drug: Recombinant Human Prourokinase |
| High Dose Experimental Group | Experimental | Recombinant Human Prourokinase:50mg Receives: Drug: Recombinant Human Prourokinase |
| Active Comparator Controlled Group | Active comparator | Alteplase:100mg if weight>=65kg, 1.5mg/kg if weight<65kg Receives: Drug: Alteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qanadli CT Score
Change of Qanadli Score from baseline by CTPA 48hours after treatment
Measured: 0 and 48hours after treatment
Average pulmonary artery pressure
Changes of average pulmonary artery pressure from baseline 24hours，48hours，7days and 30days after treatment
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 0,24hours，48hours，7days and 30days after treatment
NT-proBNP
Changes of NT-proBNP from baseline 48hours and 30days after treatment
Measured: 0，48hours and 30days after treatment
Major bleeding
The frequency of major bleeding
Measured: From baseline to 30 days
bleeding
The frequency of bleeding
Measured: From baseline to 30 days
Incidence of death from all causes
Incidence of death from all causes
Measured: From baseline to 7 days
Incidence of recurrent pulmonary embolism
Incidence of recurrent pulmonary embolism
Measured: From baseline to 7 days
Incidence of death from all causes
Incidence of death from all causes
Measured: From baseline to 30 days
Incidence of hemodynamic deterioration
Incidence of hemodynamic deterioration
Measured: From baseline to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2017
- Study start6 Jun 2017
- Primary completion19 Dec 2019
- Study completion19 Dec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Pulmonary EmbolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tasly Biopharmaceuticals Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03108833
- Sponsor's protocol ID
- TASLY-B1448
- Acronym
- ERUPTE
- Status last verified
- Mar 2021
- First submitted
- 5 Apr 2017
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cheng CY, Fan FL, Wu BX, Hua L, Zhou HM, Ying KJ, Zheng ZQ, Zhang WH, Mi YH, Xie WP, Yu ZX, Liu R, Wang DL, Xu XQ, Jing ZC; ERUPTE Investigators. Evaluation of recombinant human prourokinase for acute pulmonary embolism: A phase 2, randomized clinical trial. Med. 2026 May 8;7(5):101068. doi: 10.1016/j.medj.2026.101068. Epub 2026 Mar 30.
PubMed 41916317
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IIa Trial to Assess the Efficacy and Safety of Recombinant Human Prourokinase in the Treatment of Acute Pulmonary Embolism
- ClinicalTrials.gov ID
- NCT03108833
- Acronym / sponsor ID
- ERUPTE / TASLY-B1448
- Conditions
- Acute Pulmonary Embolism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- Tasly Biopharmaceuticals Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 6 Jun 2017 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 19 Dec 2019 (actual)
- First posted
- 11 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial is being conducted to assess the efficacy and safety of recombinant Human Prourokinase in the acute pulmonary embolism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Dose Experimental Group | Experimental | Drug: Recombinant Human ProurokinaseRecombinant Human Prourokinase:40mg |
| High Dose Experimental Group | Experimental | Drug: Recombinant Human ProurokinaseRecombinant Human Prourokinase:50mg |
| Active Comparator Controlled Group | Active comparator | Drug: AlteplaseAlteplase:100mg if weight>=65kg, 1.5mg/kg if weight<65kg |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (24 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant Human ProurokinaseAlso: rhPro-UKThe drug is used for intravenous thrombolysis therapy | Drug | High Dose Experimental Group, Low Dose Experimental Group |
| AlteplaseAlso: Actilyse, rtPAThe drug is used for intravenous thrombolysis therapy | Drug | Active Comparator Controlled Group |
Primary outcome
Qanadli CT Score
Time frame: 0 and 48hours after treatment
Change of Qanadli Score from baseline by CTPA 48hours after treatment
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
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
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
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
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
NT-proBNP
Time frame: 0，48hours and 30days after treatment
Changes of NT-proBNP from baseline 48hours and 30days after treatment
Major bleeding
Time frame: From baseline to 30 days
The frequency of major bleeding
bleeding
Time frame: From baseline to 30 days
The frequency of bleeding
Incidence of death from all causes
Time frame: From baseline to 7 days
Incidence of death from all causes
Incidence of recurrent pulmonary embolism
Time frame: From baseline to 7 days
Incidence of recurrent pulmonary embolism
Incidence of death from all causes
Time frame: From baseline to 30 days
Incidence of death from all causes
Incidence of hemodynamic deterioration
Time frame: From baseline to 7 days
Incidence of hemodynamic deterioration
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Derived from this study: PubMed 41916317Cheng CY, Fan FL, Wu BX, Hua L, Zhou HM, Ying KJ, Zheng ZQ, Zhang WH, Mi YH, Xie WP, Yu ZX, Liu R, Wang DL, Xu XQ, Jing ZC; ERUPTE Investigators. Evaluation of recombinant human prourokinase for acute pulmonary embolism: A phase 2, randomized clinical trial. Med. 2026 May 8;7(5):101068. doi: 10.1016/j.medj.2026.101068. Epub 2026 Mar 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Human Prourokinase and Alteplase in people with Acute Pulmonary Embolism, run by Tasly Biopharmaceuticals Co., Ltd. at 18 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qanadli CT Score (time frame: 0 and 48hours after treatment). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03108833, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021.