Acute Ischemic StrokePhase 2NCT04028518
A PhaseⅡ of Injection for Recombinant Human Tissue Plasminogen Kinase Derivative in Treatment of Acute Ischemic Stroke.
A Phase 2 study testing r-PA and Alteplase for Injection in people with Acute Ischemic Stroke, run by Angde Biotech Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The primary purpose of this trial is to compare the efficacy of different doses of investigator product and comparator product in patients with acute ischemic stroke in 4.5 Hours after stroke onset, and provide a basis of drug administration for phase Ⅲ clinical trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- r-PA and Alteplase for Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 20 Jul 2019to 31 Mar 2021
- 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
- Diagnosis of acute ischemic stroke according to the WHO (World Health Organization) stroke diagnostic criteria, and symptoms of stroke have existed for at least 30mins, and there is no significant improvement before treatment；
- The symptoms of acute ischemic stroke are expected to be less than 4.5 hours after the time of acute ischemic stroke which is defined as the last time the patient function well;
- NIHSS score at the time of treatment: from 4 points to 24 points (including 4 points and 24 points);
- From the signing of informed consent form to 3 months of the last dose should be the absence of a birth plan and willing to take effective contraceptive measures;
- Understand and follow the research process, voluntarily participate, and sign an informed consent form (informed consent is voluntarily signed by the person or legal representative).
Who cannot join
- Weight >120kg;
- Imaging shows multiple cerebral infarction (low density > 1/3 brain hemisphere);
- The timing of stroke symptoms is not known;
- mRS score before stroke≥ 2 points;
- NIHSS score 1a (level of consciousness) ≥ 2 points during screening;
- CT/MRI imaging examination showed signs of intracranial hemorrhage or suspected subarachnoid hemorrhage despite CT/MRI imaging findings did not show abnormalities.
Show all 20Show fewer
- Subjects have an acute bleeding tendency, including a platelet count of less than 100 × 109 / L, application of heparin or oral anticoagulant drugs (such as warfarin) within 24 hours before onset , and an INR > 1.6;
- Patients who are ready to go or have undergone endovascular treatment;
- Patients who had severe trauma or major surgery in the last 3 months (according to the investigator's assessment);
- A stroke has occurred in the last 3 months; or has a history of any stroke with diabetes;
- Severe liver damage, including liver failure, cirrhosis, portal hypertension (esophageal varices), and active hepatitis;
- Other diseases lead to patients with an expected survival time of no more than one year;
- Hypertension remains uncontrolled after active antihypertensive therapy. Uncontrolled hypertension refers to a systolic blood pressure >185 mmHg and/or a diastolic blood pressure >110 mmHg measured at intervals of at least 10mins, repeated 3 times;
- Blood glucose <50 mg/dl (equivalent to 2.78mmol/L) or >400 mg/dl (equivalent to 22.2mmol/L);
- Patients who are unable to cooperate or are unwilling to cooperate with epileptic seizures, or other mental illnesses during stroke episodes;
- Known to be allergic to research drugs or similar ingredients, or materials used in imaging studies;
- The restricted drug specified in the protocol or any drug that may interfere with the test results must be ingested or desired to continue to be ingested;
- Participating in other trials or has been participated in other trials within 30 days before randomization;
- Pregnancy or lactation, or women who have a positive pregnancy test result;
- The Subject who is unsuitable for this study in the opinion of the investigators.
Trial locations and contacts
1 site in 1 country.
China1 site
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, 100055
YongJun Wang, professor, +8613911172565, yongjunwang1962@gmail.com
About this study
Official title: A PhaseⅡ, Multicenter, Prospective Randomised, Open Blinded Endpoint Study to Evaluate Safety and Efficacy of Injection for Recombinant Human Tissue Plasminogen Kinase Derivative in Treatment of Acute Ischemic Stroke.
The primary purpose of this trial is to compare the efficacy of different doses of investigator product and comparator product in patients with acute ischemic stroke in 4.5 Hours after stroke onset, and provide a basis of drug administration for phase Ⅲ clinical trial.
The secondary purpose of this trial is to compare the safety of different dose of investigational product and comparator product in patients with acute ischemic stroke in 4.5 hours afterstroke onset .
Read the detailed description
This study is a multicenter, prospective randomised, open blinded endpoint study.
Patients with acute ischemic stroke need to undergo CT or MRI to exclude intracranial hemorrhage and perform NIHSS score before enrollment. Subjects who have passed the screening criteria according to the inclusion and exclusion criteria will be randomly assigned to low-dose test drugs, high-dose test drugs or reference drugs for thrombolytic therapy at a ratio of 1:1:1. The random stratification factor is the thrombolysis time window ("≤3h" vs "3~4.5h").
The start of administration of the study drug is recorded as 0h, CT or MRI and NIHSS score, laboratory test, and electrocardiogram were performed at 24 hours; NIHSS score was performed at 72 hours; NIHSS score，laboratory test and electrocardiogram were performed on the14th day(the start of administration is recorded as Day 1 ,then the 14th day after administration should be recorded as Day 15 ); mRS score and Barthel index score were performed on the 30th day (Day 31); mRS score and Barthel index score were performed on the 90th day (Day 91).
- Conditions
- Acute Ischemic Stroke
- Being tested
- r-PA, Alteplase for Injection
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
r-PADrug
Also called Recombinant Human Tissue Plasminogen Kinase Derivative for Injection
Drug: r-PA Dose: stick 18 mg;
Mode of admin:
The high-dose group (18 mg + 18 mg) was divided into two intravenous injections. the first intravenous bolus injection of 18mg,after 30mins, the second intravenous bolus injection of 18 mg, Push slowly for more than 2mins each time.
r-PADrug
Also called Recombinant Human Tissue Plasminogen Kinase Derivative for Injection
Drug: r-PA Dose: stick 18 mg;
Mode of admin:
The low-dose group (12 mg + 12 mg) was divided into two intravenous injections, the first intravenous bolus injection of 12 mg, after 30mins, the second intravenous bolus injection of 12 mg, Push slowly for more than 2mins each time.
Alteplase for InjectionDrug
Also called Recombinant Human Tissue Plasminogen Active for Injection
Drug: Alteplase for Injection Dose:50mg; 20mg
Mode of admin:
0.9 mg/kg (maximum dose of 90 mg) intravenous, 10% of which was injected intravenously within the first 1min, and the rest continued intravenous infusion for 1 h.
| Study group | Role | What they receive |
|---|---|---|
| The high-dose group | Experimental | Experimental: r-PA Dose: stick 18 mg;
Mode of admin:
The high-dose group (18 mg + 18 mg) was divided into two intravenous injections. the first intravenous bolus injection of 18mg,after 30mins, the second intravenous bolus injection of 18 mg, Push slowly for more than 2mins each time.Subjects were closely monitored during the medication and within 24 hours of administration. Receives: Drug: r-PA |
| The low-dose group | Experimental | Experimental: r-PA Dose: stick 18 mg;
Mode of admin:
The low-dose group (12 mg + 12 mg) was divided into two intravenous injections, the first intravenous bolus injection of 12 mg, after 30mins, the second intravenous bolus injection of 12 mg, Push slowly for more than 2mins each time.Subjects were closely monitored during the medication and within 24 hours of administration. Receives: Drug: r-PA |
| Active Comparator: Alteplase | Experimental | Active Comparator: Alteplase Drug: Alteplase for Injection Dose:50mg;20mg
Mode of admin:
0.9 mg/kg (maximum dose of 90 mg) intravenous, 10% of which was injected intravenously within the first 1min, and the rest continued intravenous infusion for 1 h. Subjects should be closely monitored during the treatment period and within 24 hours of medication.Subjects were monitored according to the "Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China 2018". Receives: Drug: Alteplase for Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with NIHSS score ≤1 or the decrease of 4 points or more from the baseline on the 14th day after treatment;
The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).
Measured: on the 14th day after treatment
Secondary outcomes (5)
The proportion of subjects with NIHSS score ≤1 or the decrease of 4 points or more from the baseline at 72 hours after treatment;
Proportion of patients with ≥4 point reduction in NIHSS or reaching 0-1 at 3 days (favourable clinical response) adjusted for baseline NIHSS and age.
Measured: at 72 hours after treatment;
The proportion of subjects with mRS score of 0-1 on the 30th day and 90th day after treatment;
The Modified Rankin Score (mRS) is a 6 point disability scale with possible scores ranging from 0-5. A separate category of 6 is usually added for patients who expire. Standardized interviews to obtain a mRS score are recommended at 3 months (90 days) following hospital discharge.
The scale runs from 0-5, running from perfect health without symptoms to Severe disability 0. -No symptoms.
- -No significant disability. Able to carry out all usual activities, despite some symptoms.
2 .-Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- -Moderate disability. Requires some help, but able to walk unassisted.
- -Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- -Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
Measured: on the 30th day and 90th day after treatment;
The proportion of subjects with mRS score of 0-2 on the 30th day and 90th day after treatment;
Measured: on the 30th day and 90th day after treatment;
Continuous changes of mRS scores on the 30th and 90th days after treatment;
Measured: on the 30th and 90th days after treatment;
The proportion of subjects with Barthel index score≥95 on the 30th day and 90th day after treatment;
The Barthel Index of Activities of Daily Living (ADLs) measures functional disability by quantifying patient performance in 10 activities of daily life. These activities can be grouped according to self-care (feeding, grooming, bathing, dressing, bowel and bladder care, and toilet use) and mobility (ambulation, transfers, and stair climbing). 5-point increments are used in scoring, with a maximal score of 100 indicating that a patient is fully independent in physical functioning, and a lowest score of 0 representing a totally dependent bed-ridden state.
Measured: on the 30th day and 90th day after treatment;
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2019
- Study start20 Jul 2019 (estimated)
- Primary completion31 Oct 2020 (estimated)
- Study completion31 Mar 2021 (estimated)
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 Ischemic StrokeStudies 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
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Angde Biotech Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04028518
- Sponsor's protocol ID
- CRAD-RTL-202
- Status last verified
- Jun 2019
- First submitted
- 13 Jun 2019
- Last updated
- 22 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li S, Wang X, Jin A, Liu G, Gu H, Li H, Campbell BCV, Fisher M, Yang Y, Wei Y, Wang J, Wang Y, Zhao X, Liu L, Li Z, Meng X, Wang Y. Safety and Efficacy of Reteplase Versus Alteplase for Acute Ischemic Stroke: A Phase 2 Randomized Controlled Trial. Stroke. 2024 Feb;55(2):366-375. doi: 10.1161/STROKEAHA.123.045193. Epub 2023 Dec 28.
PubMed 38152962
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PhaseⅡ, Multicenter, Prospective Randomised, Open Blinded Endpoint Study to Evaluate Safety and Efficacy of Injection for Recombinant Human Tissue Plasminogen Kinase Derivative in Treatment of Acute Ischemic Stroke.
- ClinicalTrials.gov ID
- NCT04028518
- Acronym / sponsor ID
- CRAD-RTL-202
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Angde Biotech Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Beijing Tiantan Hospital
- Study start
- 20 Jul 2019 (estimated)
- Primary completion
- 31 Oct 2020 (estimated)
- Study completion
- 31 Mar 2021 (estimated)
- First posted
- 22 Jul 2019 (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.
The primary purpose of this trial is to compare the efficacy of different doses of investigator product and comparator product in patients with acute ischemic stroke in 4.5 Hours after stroke onset, and provide a basis of drug administration for phase Ⅲ clinical trial.
The secondary purpose of this trial is to compare the safety of different dose of investigational product and comparator product in patients with acute ischemic stroke in 4.5 hours afterstroke onset .
Detailed description
This study is a multicenter, prospective randomised, open blinded endpoint study.
Patients with acute ischemic stroke need to undergo CT or MRI to exclude intracranial hemorrhage and perform NIHSS score before enrollment. Subjects who have passed the screening criteria according to the inclusion and exclusion criteria will be randomly assigned to low-dose test drugs, high-dose test drugs or reference drugs for thrombolytic therapy at a ratio of 1:1:1. The random stratification factor is the thrombolysis time window ("≤3h" vs "3~4.5h").
The start of administration of the study drug is recorded as 0h, CT or MRI and NIHSS score, laboratory test, and electrocardiogram were performed at 24 hours; NIHSS score was performed at 72 hours; NIHSS score，laboratory test and electrocardiogram were performed on the14th day(the start of administration is recorded as Day 1 ,then the 14th day after administration should be recorded as Day 15 ); mRS score and Barthel index score were performed on the 30th day (Day 31); mRS score and Barthel index score were performed on the 90th day (Day 91).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| The high-dose group | Experimental | Drug: r-PAExperimental: r-PA Dose: stick 18 mg; Mode of admin: The high-dose group (18 mg + 18 mg) was divided into two intravenous injections. the first intravenous bolus injection of 18mg,after 30mins, the second intravenous bolus injection of 18 mg, Push slowly for more than 2mins each time.Subjects were closely monitored during the medication and within 24 hours of administration. |
| The low-dose group | Experimental | Drug: r-PAExperimental: r-PA Dose: stick 18 mg; Mode of admin: The low-dose group (12 mg + 12 mg) was divided into two intravenous injections, the first intravenous bolus injection of 12 mg, after 30mins, the second intravenous bolus injection of 12 mg, Push slowly for more than 2mins each time.Subjects were closely monitored during the medication and within 24 hours of administration. |
| Active Comparator: Alteplase | Experimental | Drug: Alteplase for InjectionActive Comparator: Alteplase Drug: Alteplase for Injection Dose:50mg;20mg Mode of admin: 0.9 mg/kg (maximum dose of 90 mg) intravenous, 10% of which was injected intravenously within the first 1min, and the rest continued intravenous infusion for 1 h. Subjects should be closely monitored during the treatment period and within 24 hours of medication.Subjects were monitored according to the "Guidelines for the Diagnosis and Treatment of Acute Ischemic Stroke in China 2018". |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosis of acute ischemic stroke according to the WHO (World Health Organization) stroke diagnostic criteria, and symptoms of stroke have existed for at least 30mins, and there is no significant improvement before treatment；
- The symptoms of acute ischemic stroke are expected to be less than 4.5 hours after the time of acute ischemic stroke which is defined as the last time the patient function well;
- NIHSS score at the time of treatment: from 4 points to 24 points (including 4 points and 24 points);
- From the signing of informed consent form to 3 months of the last dose should be the absence of a birth plan and willing to take effective contraceptive measures;
- Understand and follow the research process, voluntarily participate, and sign an informed consent form (informed consent is voluntarily signed by the person or legal representative).
Key exclusion criteria (20 listed)
- Weight >120kg;
- Imaging shows multiple cerebral infarction (low density > 1/3 brain hemisphere);
- The timing of stroke symptoms is not known;
- mRS score before stroke≥ 2 points;
- NIHSS score 1a (level of consciousness) ≥ 2 points during screening;
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 |
|---|---|---|
| r-PAAlso: Recombinant Human Tissue Plasminogen Kinase Derivative for InjectionDrug: r-PA Dose: stick 18 mg; Mode of admin: The high-dose group (18 mg + 18 mg) was divided into two intravenous injections. the first intravenous bolus injection of 18mg,after 30mins, the second intravenous bolus injection of 18 mg, Push slowly for more than 2mins each time. | Drug | The high-dose group |
| r-PAAlso: Recombinant Human Tissue Plasminogen Kinase Derivative for InjectionDrug: r-PA Dose: stick 18 mg; Mode of admin: The low-dose group (12 mg + 12 mg) was divided into two intravenous injections, the first intravenous bolus injection of 12 mg, after 30mins, the second intravenous bolus injection of 12 mg, Push slowly for more than 2mins each time. | Drug | The low-dose group |
| Alteplase for InjectionAlso: Recombinant Human Tissue Plasminogen Active for InjectionDrug: Alteplase for Injection Dose:50mg; 20mg Mode of admin: 0.9 mg/kg (maximum dose of 90 mg) intravenous, 10% of which was injected intravenously within the first 1min, and the rest continued intravenous infusion for 1 h. | Drug | Active Comparator: Alteplase |
Primary outcome
The proportion of subjects with NIHSS score ≤1 or the decrease of 4 points or more from the baseline on the 14th day after treatment;
Time frame: on the 14th day after treatment
The National Institutes of Health Stroke Scale (NIHSS) is a 15-item neurologic examination stroke scale used to evaluate the effect of acute cerebral infarction on the levels of consciousness, language, neglect, visual-field loss, extraocular movement, motor strength, ataxia, dysarthria, and sensory loss. A trained observer rates the patent's ability to answer questions and perform activities. Ratings for each item are scored with 3 to 5 grades with 0 as normal, and there is an allowance for untestable items. The range of scores is from 0 (normal) to 42 (profound effect of stroke on patient).
5 secondary outcomes
The proportion of subjects with NIHSS score ≤1 or the decrease of 4 points or more from the baseline at 72 hours after treatment;
Time frame: at 72 hours after treatment;
The proportion of subjects with mRS score of 0-1 on the 30th day and 90th day after treatment;
Time frame: on the 30th day and 90th day after treatment;
The proportion of subjects with mRS score of 0-2 on the 30th day and 90th day after treatment;
Time frame: on the 30th day and 90th day after treatment;
Continuous changes of mRS scores on the 30th and 90th days after treatment;
Time frame: on the 30th and 90th days after treatment;
The proportion of subjects with Barthel index score≥95 on the 30th day and 90th day after treatment;
Time frame: on the 30th day and 90th day after treatment;
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2019.
- Derived from this study: PubMed 38152962Li S, Wang X, Jin A, Liu G, Gu H, Li H, Campbell BCV, Fisher M, Yang Y, Wei Y, Wang J, Wang Y, Zhao X, Liu L, Li Z, Meng X, Wang Y. Safety and Efficacy of Reteplase Versus Alteplase for Acute Ischemic Stroke: A Phase 2 Randomized Controlled Trial. Stroke. 2024 Feb;55(2):366-375. doi: 10.1161/STROKEAHA.123.045193. Epub 2023 Dec 28.
- Individual participant dataSharing planned: No
Related trials for Acute Ischemic Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
RecruitingObservational study
Continuous Dual Aspiration Technique With Zoom System for Stroke
Ischemic Stroke, Acute Stroke
Not yet recruitingPhase 2/3
A Multicenter, Open-label, Randomized, Non-inferiority Clinical Trial With Blinded Endpoint Assessment of Early Tirofiban After Intravenous Thrombolysis in Acute Ischemic Stroke
Acute Ischemic Stroke
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing r-PA and Alteplase for Injection in people with Acute Ischemic Stroke, run by Angde Biotech Pharmaceutical Co., Ltd. at 1 site 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 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: status not confirmed, as of the sponsor's last update on 22 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact YongJun Wang, Professor (+8613911172565, yongjunwang1962@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects with NIHSS score ≤1 or the decrease of 4 points or more from the baseline on the 14th day after treatment; (time frame: on the 14th day after treatment). 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 NCT04028518, 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 22 Jul 2019.