Ischemic StrokePhase 2SP-8203-2001NCT02787278
Safety and Efficacy of Two Doses of SP-8203 in Patients With Ischemic Stroke Requiring rtPA
A Phase 2 study testing SP-8203 High dose and SP-8203 Low dose in people with Ischemic Stroke, run by Shin Poong Pharmaceutical Co. Ltd. at 8 sites in South Korea.
Trial summary
The current study aims to evaluate the safety of SP-8203, designing in two stages (stage-1, stage-2) to evaluate the safety and efficacy of the combination therapy of SP-8203 and rtPA for the occurrence of cerebral hemorrhage in patients with acute ischemic stroke receiving rtPA standard of care. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- SP-8203 High dose and SP-8203 Low dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 8 sitesSouth Korea
- Study dates
- 5 Jun 2016to 22 Aug 2017
- 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Stage 1-specific Criteria Patients with neurologic deficit of ≥4 points and ≤10 points by NIHSS score.
- Stage 2-specific Criteria Patients with neurologic deficit of ≥4 points by NIHSS score.
- Common Criteria for Stage 1 and Stage 2
- Adults aged ≥19 years and ≤80 years.
- Subjects fulfilling the criteria for rtPA therapy. ① Subjects who can receive rtPA therapy within 4.5 hours after the onset of early symptoms of acute ischemic stroke.
- ② Subjects requiring rtPA therapy according to the judgment of a neurologist.
- Subjects available for brain MRI (DWI, GRE/SWI [Susceptibility Weighted Imaging], FLAIR, MRA) scanning
- Subjects who consent to participate in this trial.
Who cannot join
- Patients with systemic allergic diseases or hypersensitivity to specific drugs.
- Patients have condition as follows:
- <!-- -->
- Patients who were diagnosed with acute myocardial infarction (AMI) within the last 6 months.
- Patients who had arrhythmia causing symptoms such as dyspnea or palpitation within the last 6 months.
- Patients showing the following abnormal ECG findings in stable condition at screening:
Show all 36Show fewer
- The range of pulse rate - below 60/min or above 120/min
- 2nd or 3rd degree AV(Atrioventricular) block indicated in ECG
- Congenital or acquired QT syndrome indicated in ECG
- ④ Pre-excitation syndrome indicated in ECG
- 3) Patients with severe heart failure of NYHA(New York Heart Association) Class III or Class IV.
- NYHA classification of heart failure defined as:
- Class I: patients with no limitation of activities; they suffer no symptoms from ordinary activities.
- Class II: patients with slight, mild limitation of activity; they are comfortable with rest or with mild exertion.
- Class III: patients with marked limitation of activity; they are comfortable only at rest.
- Class IV: patients who should be at complete rest, confined to bed or chair; any physical activity brings on.
- 4) Patients with fever (≥ 38℃) or infection signs which require antibiotics at screening 5) Patients with pulmonary diseases (asthma, COPD[Chronic Obstructive Pulmonary Disease ], and active tuberculosis etc.) who have being recently been treated more than 1 month at screening, 6) Patients showing the following hematological findings: Patients with decreased hemoglobin (Hb< 10g/dL), decreased platelet count (PLT< 100,000/mm3) or hematocrit of <25% in complete blood count .
- 7) Patients who have undergone hemodialysis and/or treatments due to nephropathies, acute or chronic renal failure at screening.
- 8) Patients with a cancer in following conditions: diagnosed within 6 months before the screening time, or any treatment for cancer within the previous 6 months, or with recurrent/ metastatic cancer 9) Pregnant and breast-feeding women. However, women of childbearing age can participate in the trial only when non-pregnancy is confirmed. Woman of childbearing age is defined as woman who is not definitely menopause and did not receive a surgical contraception 10) Patients who do not consent to use double barrier contraception during the trial period.
- 11) Patients who have participated in other clinical trials of other drugs within the past 3 months. However, if they participated in observational studies and did not take drugs, they can participate in this trial.
- 12) Patients who cannot participate in the trial according to the judgment of investigators.
- 13) Patients with contraindication for the use of rtPA as shown in the below. [Contraindication for the Use of rtPA] A. Patients with hypersensitivity to gentamycin
- rtPA should not be administered when the risk of bleeding is high as follows:
- Patients who suffered from significant hemorrhagic diseases within the past 6 months or with known hemorrhagic diathesis.
- Patients receiving oral anticoagulants such as warfarin sodium (INR>1.3). iii. Patients with apparent hemorrhage or recent serious or risky hemorrhage. iv. Patients with the past history of tumor, aneurysm, or central nervous system damage such as intracranial or intraspinal operation.
- Patients with hemorrhagic retinopathy, diabetes accompanied with visual disturbance or other ophthalmic hemorrhage.
- Patients who underwent prolonged or traumatic cardiopulmonary resuscitation (>2 minutes), obstetrical delivery or recently incompressible vascular puncture within the recent 10 days.
- Patients with uncontrollable severe arterial hypertension. viii. Patients who have underwent major surgery for the recent 3 months or had recently significant trauma including all the trauma cases related with acute myocardial infarction or head trauma.
- Patients with bacterial endocarditis and pericarditis. x. Patients with acute pancreatitis. xi. Patients confirmed to have records of ulcerative gastrointestinal diseases, esophageal varix, aneurysm or arteriovenous malformation for the recent 3 months.
- Patients with severe liver diseases including hepatic failure, liver cirrhosis, portal hypertension (esophageal), or active hepatitis.
- Patients with mild neurologic deficit of <4 points on the NIHSS, or severe condition of >25 points on the NIHSS.
- Patients with seizure at onset of stroke. E. Patients with clinical presentation which suggests a subarachnoid hemorrhage, even if initial CT scan is normal.
- Patients who received heparin and have elevated active partial thromboplastin time (aPTT) within 48 hours before the onset of stroke.
- Patients who has history of stroke or had head injury within the recent 3 months.
- Patients with systolic blood pressure of >185mmHg or diastolic BP of >110mmHg, or who require aggressive treatment (intravenous administration) to reduce BP to the limits.
- Patients with blood glucose level of <50mg/dL or >400mg/dL.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
South Korea8 sites
Pusan National University Hospital
Busan
Kyungpook National University Hospital
Daegu
Myongji Hospital
Gyeonggi-do
Inje University Busan Paik Hospital
Pusan
Asan Medical Center, University of Ulsan
Seoul
Korea University Guro Hospital
Seoul
KyungHee University Medical Center
Seoul
Soonchunhyang University Hospital
Seoul
About this study
Official title: A Prospective, Randomized, Double-blinded Phase IIa Clinical Trial to Investigate the Safety and Efficacy of Two Doses of SP-8203 in Patients With Ischemic Stroke Requiring rtPA Standard of Care
The current study aims to evaluate the safety of SP-8203, designing in two stages (stage-1, stage-2) to evaluate the safety and efficacy of the combination therapy of SP-8203 and rtPA for the occurrence of cerebral hemorrhage in patients with acute ischemic stroke receiving rtPA standard of care.
Read the detailed description
As the standard procedure of rtPA therapy, rtPA will be injected intravenously using a device like infusion pump. When reperfusion is not achieved in spite of rtPA therapy, endovascular therapy can be performed according to the judgment of a site investigator.
Stage 1-The trial will be conducted with 11 subjects participating in an open label design manner. Subjects with neurologic deficit of ≥4 point and ≤10 points on NIHSS score will be given SP-8203, 80mg/dose, a total of 6 times at intervals of 12 hours. For the first administration of SP-8203, it should be administered within 30 minutes from the initiation of rtPA administration via a vein route different from one via which rtPA is injected.
Thereafter, the subject will be transferred to MRI scanning room to have brain MRI and MRA performed, and brain CT will be performed to check the occurrence of intracranial hemorrhage at 24 hours after complete administration of the first dose of SP-8203. The subject will be closely monitored by research staff daily from the day of first administration of SP-8203 (Day 0) to Day 5. Brain MRI and MRA will be followed up after the last administration of SP-8203 on Day 5. The subject will make a visit on Day 14 to have his/her neurologic symptoms checked, after which subject's participation in the trial will be completed.
*The DSMB (Date Safety Monitoring Board) meeting will be held, to decide whether to proceed with Stage 2 or not, based on the results of Stage 1.
Stage 2- A total of 69 subjects will be enrolled in double-blind, randomized and parallel design with 23 subjects assigned to low-dose (40mg/dose, 80mg/ day) SP-8203 group, high-dose (80mg/dose, 160mg/day) SP-8203 group or placebo group, respectively.
If a subject, who is able to be enrolled in Stage 2, has neurological deficit of ≥4 point on NIHSS score and give patient's consent to participate in the trial, randomization will be performed and each treatment arm (one of three) will be assigned. The subject will receive the Investigational products a total of 6 times, with 12 hours intervals. Blood sample will be taken after the sixth administration of the Investigational product for pharmacokinetic and pharmacodynamics analysis. For pharmacokinetic analysis , blood sample will be taken at 0, 30, and 120 minutes after the complete sixth administration of the investigational products. For pharmacodynamics analysis, blood sample will be taken at between 24 to 48 hours after the first administration, at 0 minute after the sixth administration and at 4th week visit.
As with Stage 1, the subject will have brain MRI and MRA performed after the administration of investigational product, and brain CT will be performed at 24 hours after completion of the first administration of investigational products.
Brain MRI and MRA will be followed-up on Day 5, similarly to Stage 1. However, in Stage 2, the subject will make a visit for close monitoring for patient's neurological condition at 4th week and 12th week. Thereafter, all the procedures of the clinical trial will be completed.
- Conditions
- Ischemic Stroke
- Being tested
- SP-8203 High dose, SP-8203 Low dose, Placebo
- Keywords
- rtPA, Intracranial hemorrhage
- Medical subject headings
- Ischemic Stroke, Intracranial Hemorrhages
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SP-8203 High doseDrug
Also called SP-8203 is produced by Shin Poong Pharmaceutical company
High-dose group: 160mg will be intravenously administered as 80mg/dose twice daily (intervals of 12 hours).
SP-8203 Low doseDrug
Also called SP-8203 is produced by Shin Poong Pharmaceutical company
Low dose group: 80mg will be intravenously administered as 40mg/dose twice daily (intervals of 12 hours).
PlaceboDrug
Same dosage of SP8203. Placebo will be intravenously administered twice daily (intervals of 12 hours)
| Study group | Role | What they receive |
|---|---|---|
| SP-8203 High dose group | Experimental | SP-8203 160mg (80mg/dose twice a day for three days) Receives: Drug: SP-8203 High dose |
| SP-8203 Low dose group | Experimental | SP-8203 80mg (40mg/dose twice a day for three days) Receives: Drug: SP-8203 Low dose |
| Placebo group | Placebo comparator | Placebo group: twice a day for three days Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ratio of the incidence of parenchymal hematoma observed on brain CT
Incidence of parenchymal hematoma observed on brain CT performed at 24 hours in accordance with European Cooperative Acute Stroke Study (ECASS) I and II criteria
Measured: Brain CT should be performed at 24 ± 3 hours after the complete administration of the first dose of IP. (Screening, Baseline ,Day 0, Day 1)
Secondary outcomes (8)
Incidence rate of serious adverse events
Incidence rate of serious adverse events
Measured: Follow up period is 30 days after the last visit.
Neurologic outcomes evaluated by modified Rankin Scale (mRS)
Neurologic outcomes evaluated by modified Rankin Scale (mRS)
Measured: Screening, Baseline, Day 0, Day 5, Week 12, Early Termination
Incidence rate symptomatic intracranial hemorrhage (sICH) occuring within 5 days
Incidence rate symptomatic intracranial hemorrhage (sICH) occuring within 5 days
Measured: Day 1 Brain CT, Day 5 Brain MRI
Neurologic outcomes evaluated by NIHSS
Neurologic outcomes evaluated by NIHSS
Measured: NIHSS should be scored every visit
Neurologic outcomes evaluated by Barthel Index
Neurologic outcomes evaluated by Barthel Index
Measured: Day 0, Day 5, Week 12, Early Termination
The rate of death due to any cause
The rate of death due to any cause
Measured: it is expected that a follow-up for up to 30 days after the last visit.
Incidence rate of adverse events and adverse drug reactions
Incidence rate of adverse events and adverse drug reactions
Measured: it is expected that a follow-up for up to 30 days after the last visit.
Incidence rate of major systemic bleeding according to the International Society on Thrombosis and Hemostasis (ISTH
Incidence rate of major systemic bleeding according to the International Society on Thrombosis and Hemostasis (ISTH
Measured: Laboratory tests (hematological test, clinical chemistry test, urinalysis etc.)- Day 1, Day 3, Day-5, Week 4, Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start5 Jun 2016
- Primary completion30 May 2017
- Study completion22 Aug 2017
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 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
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jong Sung Kim, MD, Phd, Principal investigator, Department of Neurology, Asan Medical Center, Seoul, South Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02787278
- Sponsor's protocol ID
- SP-8203-2001
- Acronym
- SP-8203-2001
- Status last verified
- Jul 2020
- First submitted
- 18 May 2016
- Last updated
- 21 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kim JS, Lee KB, Park JH, Sung SM, Oh K, Kim EG, Chang DI, Hwang YH, Lee EJ, Kim WK, Ju C, Kim BS, Ryu JM; SAFE-TPA Investigators. Safety and Efficacy of Otaplimastat in Patients with Acute Ischemic Stroke Requiring tPA (SAFE-TPA): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study. Ann Neurol. 2020 Feb;87(2):233-245. doi: 10.1002/ana.25644. Epub 2019 Nov 29.
PubMed 31721277
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Double-blinded Phase IIa Clinical Trial to Investigate the Safety and Efficacy of Two Doses of SP-8203 in Patients With Ischemic Stroke Requiring rtPA Standard of Care
- ClinicalTrials.gov ID
- NCT02787278
- Acronym / sponsor ID
- SP-8203-2001 / SP-8203-2001
- Conditions
- Ischemic Stroke
- Keywords
- rtPA, Intracranial hemorrhage
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Shin Poong Pharmaceutical Co. Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2016 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 22 Aug 2017 (actual)
- First posted
- 1 Jun 2016 (estimated)
- 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 current study aims to evaluate the safety of SP-8203, designing in two stages (stage-1, stage-2) to evaluate the safety and efficacy of the combination therapy of SP-8203 and rtPA for the occurrence of cerebral hemorrhage in patients with acute ischemic stroke receiving rtPA standard of care.
Detailed description
As the standard procedure of rtPA therapy, rtPA will be injected intravenously using a device like infusion pump. When reperfusion is not achieved in spite of rtPA therapy, endovascular therapy can be performed according to the judgment of a site investigator.
Stage 1-The trial will be conducted with 11 subjects participating in an open label design manner. Subjects with neurologic deficit of ≥4 point and ≤10 points on NIHSS score will be given SP-8203, 80mg/dose, a total of 6 times at intervals of 12 hours. For the first administration of SP-8203, it should be administered within 30 minutes from the initiation of rtPA administration via a vein route different from one via which rtPA is injected.
Thereafter, the subject will be transferred to MRI scanning room to have brain MRI and MRA performed, and brain CT will be performed to check the occurrence of intracranial hemorrhage at 24 hours after complete administration of the first dose of SP-8203. The subject will be closely monitored by research staff daily from the day of first administration of SP-8203 (Day 0) to Day 5. Brain MRI and MRA will be followed up after the last administration of SP-8203 on Day 5. The subject will make a visit on Day 14 to have his/her neurologic symptoms checked, after which subject's participation in the trial will be completed.
*The DSMB (Date Safety Monitoring Board) meeting will be held, to decide whether to proceed with Stage 2 or not, based on the results of Stage 1.
Stage 2- A total of 69 subjects will be enrolled in double-blind, randomized and parallel design with 23 subjects assigned to low-dose (40mg/dose, 80mg/ day) SP-8203 group, high-dose (80mg/dose, 160mg/day) SP-8203 group or placebo group, respectively.
If a subject, who is able to be enrolled in Stage 2, has neurological deficit of ≥4 point on NIHSS score and give patient's consent to participate in the trial, randomization will be performed and each treatment arm (one of three) will be assigned. The subject will receive the Investigational products a total of 6 times, with 12 hours intervals. Blood sample will be taken after the sixth administration of the Investigational product for pharmacokinetic and pharmacodynamics analysis. For pharmacokinetic analysis , blood sample will be taken at 0, 30, and 120 minutes after the complete sixth administration of the investigational products. For pharmacodynamics analysis, blood sample will be taken at between 24 to 48 hours after the first administration, at 0 minute after the sixth administration and at 4th week visit.
As with Stage 1, the subject will have brain MRI and MRA performed after the administration of investigational product, and brain CT will be performed at 24 hours after completion of the first administration of investigational products.
Brain MRI and MRA will be followed-up on Day 5, similarly to Stage 1. However, in Stage 2, the subject will make a visit for close monitoring for patient's neurological condition at 4th week and 12th week. Thereafter, all the procedures of the clinical trial will be completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SP-8203 High dose group | Experimental | Drug: SP-8203 High doseSP-8203 160mg (80mg/dose twice a day for three days) |
| SP-8203 Low dose group | Experimental | Drug: SP-8203 Low doseSP-8203 80mg (40mg/dose twice a day for three days) |
| Placebo group | Placebo comparator | Drug: PlaceboPlacebo group: twice a day for three days |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Stage 1-specific Criteria Patients with neurologic deficit of ≥4 points and ≤10 points by NIHSS score.
- Stage 2-specific Criteria Patients with neurologic deficit of ≥4 points by NIHSS score.
- Common Criteria for Stage 1 and Stage 2
- Adults aged ≥19 years and ≤80 years.
- Subjects fulfilling the criteria for rtPA therapy. ① Subjects who can receive rtPA therapy within 4.5 hours after the onset of early symptoms of acute ischemic stroke.
Key exclusion criteria (36 listed)
- Patients with systemic allergic diseases or hypersensitivity to specific drugs.
- Patients have condition as follows:
- <!-- -->
- Patients who were diagnosed with acute myocardial infarction (AMI) within the last 6 months.
- Patients who had arrhythmia causing symptoms such as dyspnea or palpitation within the last 6 months.
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 |
|---|---|---|
| SP-8203 High doseAlso: SP-8203 is produced by Shin Poong Pharmaceutical companyHigh-dose group: 160mg will be intravenously administered as 80mg/dose twice daily (intervals of 12 hours). | Drug | SP-8203 High dose group |
| SP-8203 Low doseAlso: SP-8203 is produced by Shin Poong Pharmaceutical companyLow dose group: 80mg will be intravenously administered as 40mg/dose twice daily (intervals of 12 hours). | Drug | SP-8203 Low dose group |
| PlaceboSame dosage of SP8203. Placebo will be intravenously administered twice daily (intervals of 12 hours) | Drug | Placebo group |
Primary outcome
The ratio of the incidence of parenchymal hematoma observed on brain CT
Time frame: Brain CT should be performed at 24 ± 3 hours after the complete administration of the first dose of IP. (Screening, Baseline ,Day 0, Day 1)
Incidence of parenchymal hematoma observed on brain CT performed at 24 hours in accordance with European Cooperative Acute Stroke Study (ECASS) I and II criteria
8 secondary outcomes
Incidence rate of serious adverse events
Time frame: Follow up period is 30 days after the last visit.
Neurologic outcomes evaluated by modified Rankin Scale (mRS)
Time frame: Screening, Baseline, Day 0, Day 5, Week 12, Early Termination
Incidence rate symptomatic intracranial hemorrhage (sICH) occuring within 5 days
Time frame: Day 1 Brain CT, Day 5 Brain MRI
Neurologic outcomes evaluated by NIHSS
Time frame: NIHSS should be scored every visit
Neurologic outcomes evaluated by Barthel Index
Time frame: Day 0, Day 5, Week 12, Early Termination
The rate of death due to any cause
Time frame: it is expected that a follow-up for up to 30 days after the last visit.
Incidence rate of adverse events and adverse drug reactions
Time frame: it is expected that a follow-up for up to 30 days after the last visit.
Incidence rate of major systemic bleeding according to the International Society on Thrombosis and Hemostasis (ISTH
Time frame: Laboratory tests (hematological test, clinical chemistry test, urinalysis etc.)- Day 1, Day 3, Day-5, Week 4, Week 12
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 21 Jul 2020.
- Derived from this study: PubMed 31721277Kim JS, Lee KB, Park JH, Sung SM, Oh K, Kim EG, Chang DI, Hwang YH, Lee EJ, Kim WK, Ju C, Kim BS, Ryu JM; SAFE-TPA Investigators. Safety and Efficacy of Otaplimastat in Patients with Acute Ischemic Stroke Requiring tPA (SAFE-TPA): A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 2 Study. Ann Neurol. 2020 Feb;87(2):233-245. doi: 10.1002/ana.25644. Epub 2019 Nov 29.
- 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.
Jong Sung Kim, MD, Phd principal investigator
Department of Neurology, Asan Medical Center, Seoul, South Korea
8 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 SP-8203 High dose and SP-8203 Low dose in people with Ischemic Stroke, run by Shin Poong Pharmaceutical Co. Ltd. at 8 sites in South Korea.
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 8 inclusion and 36 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 21 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in South Korea. 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. Some participants in this study may receive a placebo. 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?
The ratio of the incidence of parenchymal hematoma observed on brain CT (time frame: Brain CT should be performed at 24 ± 3 hours after the complete administration of the first dose of IP. (Screening, Baseline ,Day 0, Day 1)). 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 NCT02787278, 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 21 Jul 2020.