Massive Pulmonary EmbolismPhase 3NCT04688320
Massive Pulmonary Embolism: Trial of Non-immunogenic Recombinant Staphylokinase VS Alteplase FORPE
A Phase 3 study testing Recombinant nonimmunogenic staphylokinase and Alteplase in people with Massive Pulmonary Embolism, run by Supergene, LLC at 23 sites in Russia.
Trial summary
Objective: to evaluate the efficacy and safety of the Recombinant Non-immunogenic Staphylokinase with its single bolus administration in comparison with the bolus-infusion administration of the Alteplase in patients with massive pulmonary embolism Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Massive Pulmonary Embolism
- What is being tested?
- Recombinant nonimmunogenic staphylokinase and Alteplase
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 310 participants
- Where
- 23 sitesRussia
- Study dates
- 15 Dec 2020to 27 Jul 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women aged 18 and over
- Verified diagnosis of massive PE (using MSCT with PA contrast)
- Signs of overload / dysfunction of the right ventricle (at least one) in combination with persistent arterial hypotension or shock
- Patient consent to use reliable contraceptive methods throughout the study and for 3 weeks after:
- women who have a negative pregnancy test and use the following contraceptives: intrauterine devices, oral contraceptives, contraceptive patch, prolonged injectable contraceptives, double barrier method of contraception. Women who are not fertile can also take part in the study (documented conditions: hysterectomy, tubal ligation, infertility, menopause for more than 1 year);
- men using barrier contraception. The study may also involve men who are not fertile (documented conditions: vasectomy, infertility)
- Availability of signed and dated informed consent of the patient to participate in the study.
Who cannot join
- • Increased risk of bleeding:
- Extensive bleeding at present or within the previous 6 months, hemorrhagic diathesis;
- Intracranial (including subarachnoid) hemorrhage at present or in history, suspected hemorrhagic stroke;
- A history of hemorrhagic stroke or stroke of unknown etiology;
- Ischemic stroke or transient ischemic attack within the last 6 months, except for the current acute ischemic stroke within 4.5 hours;
- A history of diseases of the central nervous system (including neoplasms, aneurysms, surgery on the brain or spinal cord);
Show all 20Show fewer
- Major surgery or major trauma within the previous 3 months, recent traumatic brain injury;
- Long-term or traumatic cardiopulmonary resuscitation (> 2 min), delivery within the previous 10 days, recent puncture of an uncompressible blood vessel (eg, subclavian or jugular vein);
- Severe liver disease, including liver failure, cirrhosis, portal hypertension (including esophageal varices) and active hepatitis;
- Confirmed gastric or duodenal ulcer within the last three months;
- Neoplasm with an increased risk of bleeding;
- Concurrent administration of oral anticoagulants, for example, warfarin with an INR> 1.3;
- Arterial aneurysms, developmental defects of arteries / veins;
- Severe uncontrolled arterial hypertension;
- Acute pancreatitis;
- Bacterial endocarditis, pericarditis;
- suspicion of aortic dissecting aneurysm;
- any other conditions, in the opinion of the doctor, associated with a high risk of bleeding.
- Lactation, pregnancy
- Known hypersensitivity to Alteplase, Fortelizin.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
Russia23 sites
Belgorod Regional Clinical Hospital of St. Joseph
Belgorod, 308007
Kuzbass Cardiology center
Kemerovo, 650002
Krasnoyarsk Regional Clinical Hospital
Krasnoyarsk, 660022
Kursk Regional Clinical Hospital
Kursk, 305007
D.D. Pletnev City Clinical Hospital
Moscow, 105077
I.V. Davydovskii City Clinical Hospital
Moscow, 109240
S.S. Yudin City Clinical Hospital
Moscow, 115446
V.V. Vinogradov City Clinical Hospital
Moscow, 117292
V.V. Veresaev City Clinical Hospital
Moscow, 127644
N.V. Sklifosovsky Research Institute for Emergency Medicine
Moscow, 129090
S.P. Botkin City Clinical Hospital
Moscow
Murmansk Regional Clinical Hospital
Murmansk, 183047
N.N. Burdenko Penza Regional Clinical hospital
Penza, 440026
G.A. Zakharyin Clinical hospital №6
Penza, 440071
Saint Petersburg "Mariinskaya" City Hospital
Saint Petersburg, 191014
Holy Martyr Elizabeth Saint Petersburg City Hospital
Saint Petersburg, 195257
V.P. Polyakov Samara Regional Clinical Cardiology Dispensary
Samara, 443070
Saratov Regional Clinical Cardiology Dispensary
Saratov, 410039
Sergiyev Posad Regional Clinical Hospital
Sergiyev Posad, Moscow Oblast, 141301
Tver Regional Clinical Hospital
Tver', 170036
City Clinical hospital №4
Vladimir, 600009
City Clinical Hospital of Emergency №25
Volgograd, 400138
V.F. Dolgopolov Vyselki Central District Hospital
Vyselki, Krasnodarskiy Kray, 353100
About this study
Official title: Multicenter, Open Label, Randomized Comparative Trial of the Efficacy and Safety of a Single Bolus Recombinant Non-immunogenic Staphylokinase and Bolus-infusion of Alteplase in Patients With Massive Pulmonary Embolism (FORPE)
Objective: to evaluate the efficacy and safety of the Recombinant Non-immunogenic Staphylokinase with its single bolus administration in comparison with the bolus-infusion administration of the Alteplase in patients with massive pulmonary embolism
Read the detailed description
The main goal of treating massive PE is to save the lives of patients by restoring pulmonary perfusion, preventing the development of chronic postembolic pulmonary hypertension and recurrent PE. According to data of clinical trials, with timely initiation of therapy for massive pulmonary embolism, mortality can be significantly reduced.
Recombinant protein which contains aminoacid sequence of staphylokinase - Fortelizin® (the active substance is Forteplase). It is single chain molecula, consists of 138 aminoacids, weight 15.5 kDa. When staphylokinase is added to human plasma containing a fibrin clot, it preferentially reacts with plasmin at the clot surface, forming a plasmin-staphylokinase complex. This complex activates plasminogen trapped in the thrombus. The plasmin-staphylokinase complex and plasmin bound to fibrin are protected from inhibition by alpha2-antiplasmin. Once liberated from the clot (or generated in plasma), however, they are rapidly inhibited by alpha2-antiplasmin. This selectivity of action confines the process of plasminogen activation to the thrombus, preventing excessive plasmin generation, alpha2-antiplasmin depletion, and fibrinogen degradation in plasma. In rabbits anti forteplase antibodies are not produced. It was achieved by replacement of amino acids in immunogenic epitop of molecule staphylokinase. Blood fibrinogen decrease after i.v. injection of Fortelyzin less 10% within first 24 hours. Angiographic data suggests that restoration of coronary blood flow appears in up to 80% of patients with STEMI after i.v. injection of Fortelyzin.
The main objectives of the study: to assess the efficacy, safety and possible adverse events of the drug Recombinant Non-immunogenic Staphylokinase with its single bolus administration in comparison with the bolus-infusion administration of the drug Alteplase® in patients with massive pulmonary embolism.
Study Design. Multicenter, open-label, randomized, comparative clinical study of non-inferiority study of efficacy and safety in parallel groups. At clinical centers, patients will be equally randomly distributed by the "envelope" method into two groups of 155 patients each (310 people in total, including 10% of those who may have dropped out)to receive Recombinant Non-immunogenic Staphylokinase or Alteplase®.
The drugs will be administered after the signed informed consent. Recombinant Non-immunogenic Staphylokinase will be administered intravenously at a dose of 15 mg as a single bolus for 10-15 seconds. Alteplase® will be administered in accordance with the instructions for use.
Patients will be monitored for 30 days from the moment of randomization: in the intensive care unit up to 7 days, after it in the hospital until discharge - an average of 14 days and an outpatient visits on the 30th day. The recruitment of patients for the study will be competitive.
- Conditions
- Massive Pulmonary Embolism
- Being tested
- Recombinant nonimmunogenic staphylokinase, Alteplase
- Keywords
- Massive pulmonary embolism, Fibrinolysis, Recombinant Non-immunogenic Staphylokinase
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant nonimmunogenic staphylokinaseDrug
Also called Fortelyzin
15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds
AlteplaseDrug
Also called Actillyze
Alteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant nonimmunogenic staphylokinase | Experimental | lyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. Receives: Drug: Recombinant nonimmunogenic staphylokinase |
| Alteplase | Experimental | Alteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. Receives: Drug: Alteplase |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death From All Causes
The efficacy is evaluated in terms of the number of deaths from all causes
Measured: within 7 days
Secondary outcomes (9)
Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5)
The efficacy is evaluated in terms of systolic pulmonary artery pressure values
Measured: baseline and day 1, 7, 14 after randomisation
Haemodynamic Collapse
The efficacy is evaluated in terms of the number of haemodynamic collapse
Measured: within 7 days
Recurrent Pulmonary Embolism (PE)
The efficacy is evaluated in terms of the number of recurrent PE
Measured: within 7 days
Death From PE
The efficacy is evaluated in terms of the number of deaths from PE
Measured: within 30 days
Death From All Causes
The efficacy is evaluated in terms of the number of deaths from all causes
Measured: within 30 days
Haemodynamic Collapse Within 7 Days + Recurrent PE Within 7 Days + Death From All Causes Within 30 Days
The efficacy is evaluated in terms of the number of haemodynamic collapse + recurrent PE + deaths from all causes
Measured: within 30 days
Safety Endpoint - Haemorrhagic Stroke
The safety is evaluated in terms of the number of haemorrhagic stroke within 7 days of randomisation
Measured: within 7 days
Safety Endpoint - BARC Type 3+5 Bleeding
The safety is evaluated in terms of the number of BARC type 3+5 bleeding. Type 3a: overt bleeding plus a hemoglobin drop of 3 to 5 g/dL; any transfusion with overt bleeding.
Type 3b: overt bleeding plus a hemoglobin drop of 5 g/dL; cardiac tamponade; bleeding requiring surgical intervention for control; bleeding requiring intravenous vasoactive agents.
Type 3c: intracranial hemorrhage (does not include microbleeds or hemorrhagic transformation, does include intraspinal); subcategories confirmed by autopsy or imaging, or lumbar puncture; intraocular bleed compromising vision.
Type 5a: probable fatal bleeding; no autopsy or imaging confirmation but clinically suspicious.
Type 5b: definite fatal bleeding; overt bleeding or autopsy, or imaging confirmation.
Measured: within 30 days
Safety Endpoint - Number and Severity of Serious Adverse Events (SAEs)
The safety is evaluated in terms of the number and severity of serious adverse events (SAEs)
Measured: within 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start15 Dec 2020
- Primary completion27 Jul 2023
- Study completion27 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Massive 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- At clinical centers, patients will be equally randomly distributed by the "envelope method" into two groups to receive Fortelizin® or Alteplase®. The drugs will be administered after the signed informed consent. Fortelizin® will be administered intravenously at a dose of 15 mg as a single bolus for 10-15 seconds. Alteplase® will be administered in accordance with the instructions for use. All patients will be examination for 30 days.
- Masking
- None (open label)
- Enrolment
- 310 participants (actual)
Sponsor and investigators
- Lead sponsor
- Supergene, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alexander I Kirienko, MD, PhD, Principal investigator, Pirogov Russian National Research Medical UniversitySergey S Markin, MD, PhD, Study director, Supergene, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688320
- Sponsor's protocol ID
- FORPE
- Status last verified
- Mar 2025
- First submitted
- 18 Dec 2020
- Last updated
- 2 Apr 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Leontyev SG, Yarovaya EB, Kutsenko VA, Ivlev OE, Soplenkova AG, Semenov AM, Semenov MP, Ivanov SV, Romashova YA, Markin SS. The Safety of Non-immunogenic Recombinant Staphylokinase in Elderly Patients With Massive Pulmonary Embolism: A Randomized Clinical Trial FORPE. Health Sci Rep. 2025 May 19;8(5):e70826. doi: 10.1002/hsr2.70826. eCollection 2025 May.
PubMed 40391253
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Open Label, Randomized Comparative Trial of the Efficacy and Safety of a Single Bolus Recombinant Non-immunogenic Staphylokinase and Bolus-infusion of Alteplase in Patients With Massive Pulmonary Embolism (FORPE)
- ClinicalTrials.gov ID
- NCT04688320
- Acronym / sponsor ID
- FORPE
- Conditions
- Massive Pulmonary Embolism
- Keywords
- Massive pulmonary embolism, Fibrinolysis, Recombinant Non-immunogenic Staphylokinase
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- Supergene, LLCIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2020 (actual)
- Primary completion
- 27 Jul 2023 (actual)
- Study completion
- 27 Jul 2023 (actual)
- First posted
- 29 Dec 2020 (actual)
- Results
- Posted 2 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objective: to evaluate the efficacy and safety of the Recombinant Non-immunogenic Staphylokinase with its single bolus administration in comparison with the bolus-infusion administration of the Alteplase in patients with massive pulmonary embolism
Detailed description
The main goal of treating massive PE is to save the lives of patients by restoring pulmonary perfusion, preventing the development of chronic postembolic pulmonary hypertension and recurrent PE. According to data of clinical trials, with timely initiation of therapy for massive pulmonary embolism, mortality can be significantly reduced.
Recombinant protein which contains aminoacid sequence of staphylokinase - Fortelizin® (the active substance is Forteplase). It is single chain molecula, consists of 138 aminoacids, weight 15.5 kDa. When staphylokinase is added to human plasma containing a fibrin clot, it preferentially reacts with plasmin at the clot surface, forming a plasmin-staphylokinase complex. This complex activates plasminogen trapped in the thrombus. The plasmin-staphylokinase complex and plasmin bound to fibrin are protected from inhibition by alpha2-antiplasmin. Once liberated from the clot (or generated in plasma), however, they are rapidly inhibited by alpha2-antiplasmin. This selectivity of action confines the process of plasminogen activation to the thrombus, preventing excessive plasmin generation, alpha2-antiplasmin depletion, and fibrinogen degradation in plasma. In rabbits anti forteplase antibodies are not produced. It was achieved by replacement of amino acids in immunogenic epitop of molecule staphylokinase. Blood fibrinogen decrease after i.v. injection of Fortelyzin less 10% within first 24 hours. Angiographic data suggests that restoration of coronary blood flow appears in up to 80% of patients with STEMI after i.v. injection of Fortelyzin.
The main objectives of the study: to assess the efficacy, safety and possible adverse events of the drug Recombinant Non-immunogenic Staphylokinase with its single bolus administration in comparison with the bolus-infusion administration of the drug Alteplase® in patients with massive pulmonary embolism.
Study Design. Multicenter, open-label, randomized, comparative clinical study of non-inferiority study of efficacy and safety in parallel groups. At clinical centers, patients will be equally randomly distributed by the "envelope" method into two groups of 155 patients each (310 people in total, including 10% of those who may have dropped out)to receive Recombinant Non-immunogenic Staphylokinase or Alteplase®.
The drugs will be administered after the signed informed consent. Recombinant Non-immunogenic Staphylokinase will be administered intravenously at a dose of 15 mg as a single bolus for 10-15 seconds. Alteplase® will be administered in accordance with the instructions for use.
Patients will be monitored for 30 days from the moment of randomization: in the intensive care unit up to 7 days, after it in the hospital until discharge - an average of 14 days and an outpatient visits on the 30th day. The recruitment of patients for the study will be competitive.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- At clinical centers, patients will be equally randomly distributed by the "envelope method" into two groups to receive Fortelizin® or Alteplase®. The drugs will be administered after the signed informed consent. Fortelizin® will be administered intravenously at a dose of 15 mg as a single bolus for 10-15 seconds. Alteplase® will be administered in accordance with the instructions for use. All patients will be examination for 30 days.
| Arm | Type | Receives |
|---|---|---|
| Recombinant nonimmunogenic staphylokinase | Experimental | Drug: Recombinant nonimmunogenic staphylokinaselyophilisate for preparation of a solution for intravenous administration, 5 mg (745,000 IU) complete with a solvent. 15 mg (2,235,000 IU) - 3 vials, intravenously as a quick single bolus injection for 10-15 seconds, regardless of body weight. |
| Alteplase | Experimental | Drug: AlteplaseAlteplase® is administered in accordance with the instructions for use for pulmonary embolism( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Men and women aged 18 and over
- Verified diagnosis of massive PE (using MSCT with PA contrast)
- Signs of overload / dysfunction of the right ventricle (at least one) in combination with persistent arterial hypotension or shock
- Patient consent to use reliable contraceptive methods throughout the study and for 3 weeks after:
- Availability of signed and dated informed consent of the patient to participate in the study.
Key exclusion criteria (20 listed)
- • Increased risk of bleeding:
- Lactation, pregnancy
- Known hypersensitivity to Alteplase, Fortelizin.
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 nonimmunogenic staphylokinaseAlso: Fortelyzin15 mg of drug reconstituted in 10 ml of 0.9% solution of NaCl given as single i.v. bolus over 10-15 seconds | Drug | Recombinant nonimmunogenic staphylokinase |
| AlteplaseAlso: ActillyzeAlteplase® is administered in accordance with the instructions for use for pulmonary embolism ( 10 mg bolus and 90 mg as IV infusion over 2 hours, maximum 100 mg). In patients weighing less than 65 kg, the total dose should not exceed 1.5 mg / kg. | Drug | Alteplase |
Primary outcome
Death From All Causes
Time frame: within 7 days
The efficacy is evaluated in terms of the number of deaths from all causes
9 secondary outcomes
Systolic Pulmonary Artery Pressure Measures (V1, V2, V4, V5)
Time frame: baseline and day 1, 7, 14 after randomisation
Haemodynamic Collapse
Time frame: within 7 days
Recurrent Pulmonary Embolism (PE)
Time frame: within 7 days
Death From PE
Time frame: within 30 days
Death From All Causes
Time frame: within 30 days
Haemodynamic Collapse Within 7 Days + Recurrent PE Within 7 Days + Death From All Causes Within 30 Days
Time frame: within 30 days
Safety Endpoint - Haemorrhagic Stroke
Time frame: within 7 days
Safety Endpoint - BARC Type 3+5 Bleeding
Time frame: within 30 days
Safety Endpoint - Number and Severity of Serious Adverse Events (SAEs)
Time frame: within 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 40391253Leontyev SG, Yarovaya EB, Kutsenko VA, Ivlev OE, Soplenkova AG, Semenov AM, Semenov MP, Ivanov SV, Romashova YA, Markin SS. The Safety of Non-immunogenic Recombinant Staphylokinase in Elderly Patients With Massive Pulmonary Embolism: A Randomized Clinical Trial FORPE. Health Sci Rep. 2025 May 19;8(5):e70826. doi: 10.1002/hsr2.70826. eCollection 2025 May.
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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.
Alexander I Kirienko, MD, PhD principal investigator
Pirogov Russian National Research Medical University
Sergey S Markin, MD, PhD study director
Supergene, LLC
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant nonimmunogenic staphylokinase and Alteplase in people with Massive Pulmonary Embolism, run by Supergene, LLC at 23 sites in Russia.
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 7 inclusion and 20 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 2 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Russia. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Death From All Causes (time frame: within 7 days). 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 NCT04688320, 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 2 Apr 2025.