Acute Ischemic StrokePhase 2NCT03062397
Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke
A Phase 2 study testing JPI-289 Low-dose and JPI-289 High-dose in people with Acute Ischemic Stroke, run by Jeil Pharmaceutical Co., Ltd. at 15 sites in South Korea.
Trial summary
Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Acute Ischemic Stroke
- What is being tested?
- JPI-289 Low-dose and JPI-289 High-dose
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 15 sitesSouth Korea
- Study dates
- 9 Dec 2016to Dec 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects with acute ischemic stroke, aging ≥ 19
- Confirmed to have acute anterior circulation cerebral artery occlusion in intracranial internal carotid artery (IICA) or middle cerebral artery (MCA) M1 segment by CT or MR angiography.
- National Institutes of Health Stroke Scale(NIHSS) is 6~30 before endovascular recanalization therapy (ERT)
- Subject who is reperfused with 2b or 3 stages of thrombolysis in cerebral infarction (TICI) (However, if angiography is conducted for thrombectomy after IV tPA treatment and the effect of tPA results in TICI 2b-3 reperfusion, the subject can participate)
- Subject who can administer IP within 6.5 hrs of symptom development
- Subject who can administer IP within 30 min of vascular reperfusion
- Subject who can evaluate MRI within 90 min of vascular reperfusion
Who cannot join
- Subject who is contraindicated for endovascular recanalization
- Subject who has hypersensitivity to contrast agent or component of investigational product
- Prohibited or unable to perform MRI test
- Medical history that is related to bleeding
- History of hemorrhagic stroke within 6 months of study participation
- Subjects with chronic liver disorder
Show all 13Show fewer
- Kidney disorder (Serum creatinine > 3 mg/dL)
- Life expectancy is less than 3 months due to concomitant disease other than stroke
- Pregnant or lactating women
- Those who have taken tirofiban (anticoagulant agent) during endovascular recanalization therapy
- Those who have taken other investigational drugs and/or medical instruments 12 weeks prior to screening
- Subject is unable to be followed up
- Subject is deemed unable to participate the study in the opinion of the investigator.
Trial locations and contacts
15 sites in 1 country.
Byung Woo Yoon, MD., PhD contact
Yong Woo Lee, MSC contact
15 sites in 1 country
South Korea15 sites, 15 recruiting
- Recruiting
Dong-A University Hospital
Busan
Jae Kwan Cha, MD., PhD, nrcjk65@gmail.com
- Recruiting
Inje University Busan Paik Hospital
Busan
Eung-Gyu Kim, MD., PhD
- Recruiting
Gyeongsang National University Changwon Hospital
Changwon
Seunguk Jung, MD
- Recruiting
Yeungnam University Medical Center
Daegu
Jun Lee, MD., PhD, junlee@ynu.ac.kr
- Recruiting
Chonnam National University Hospital
Gwangju
Man Seok Park, MD., PhD, mspark@chonnam.ac.kr
- Recruiting
Inje University Ilsan Paik Hospital
Gyeonggi-do
Keun Sik Hong, MD., PhD, nrhks@paik.ac.kr
- Recruiting
Seoul National University Bundang Hospital
Gyeonggi-do
Moon Ku Han, MD., PhD, mkhan@snu.ac.kr
- Recruiting
Catholic Kwandong University International St. Mary'S Hospital
Incheon
Sang Joon An, MD
- Recruiting
Jeju National University Hospital
Jeju City
Jay Chol Choi, M.D., PhD, jaychoi@jejunu.ac.kr
- Recruiting
Gyeongsang National University Hospital
Jinju
Chang Heon Kim, MD.,PhD, honey0407@naver.com
- Recruiting
Pusan National University Hospital
Pusan
Sang Min Sung, MD. PhD, aminoff@hanmail.net
- Recruiting
Ewha Womans University Seoul Hospital
Seoul
Tae Jin Song, MD., PhD
- Recruiting
Hanyang University Hospital
Seoul
Young Seo Kim, MD. PhD, aescula@daum.net
- Recruiting
Korea University Guro Hospital
Seoul
Kyung Mi Oh, MD., PhD, okyungmi@korea.ac.kr
- Recruiting
Seoul National University Hospital
Seoul
Byung Woo Yoon, MD., PhD, bwyoon@snu.ac.kr
About this study
Official title: A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke
Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke
- Conditions
- Acute Ischemic Stroke
- Being tested
- JPI-289 Low-dose, JPI-289 High-dose, Placebo
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JPI-289 Low-doseDrug
JPI-289 Low dose will be intravenously administered during 24 hours
JPI-289 High-doseDrug
JPI-289 High dose will be intravenously administered during 24 hours
PlaceboDrug
Same dosage of JPI-289 Low and Hogh dose will be intravenously administered during 24 hours
| Study group | Role | What they receive |
|---|---|---|
| Low-dose group | Experimental | JPI-289 Low dose or placebo Receives: Drug: JPI-289 Low-dose |
| High-dose group | Experimental | JPI-289 High dose or placebo Receives: Drug: JPI-289 High-dose |
| Placebo group | Placebo comparator | Same dosage of JPI-289 low and high dose Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Infact growth ratio from baseline
Measured: 4 days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start9 Dec 2016
- Primary completionDec 2020 (estimated)
- Study completionDec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062397
- Sponsor's protocol ID
- JPI-289-P2
- Status last verified
- Nov 2019
- First submitted
- 20 Feb 2017
- Last updated
- 18 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Placebo-controlled, Phase IIa Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03062397
- Acronym / sponsor ID
- JPI-289-P2
- Conditions
- Acute Ischemic Stroke
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Jeil Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 9 Dec 2016 (actual)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 23 Feb 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.
Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low-dose group | Experimental | Drug: JPI-289 Low-doseJPI-289 Low dose or placebo |
| High-dose group | Experimental | Drug: JPI-289 High-doseJPI-289 High dose or placebo |
| Placebo group | Placebo comparator | Drug: PlaceboSame dosage of JPI-289 low and high dose |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects with acute ischemic stroke, aging ≥ 19
- Confirmed to have acute anterior circulation cerebral artery occlusion in intracranial internal carotid artery (IICA) or middle cerebral artery (MCA) M1 segment by CT or MR angiography.
- National Institutes of Health Stroke Scale(NIHSS) is 6~30 before endovascular recanalization therapy (ERT)
- Subject who is reperfused with 2b or 3 stages of thrombolysis in cerebral infarction (TICI) (However, if angiography is conducted for thrombectomy after IV tPA treatment and the effect of tPA results in TICI 2b-3 reperfusion, the subject can participate)
- Subject who can administer IP within 6.5 hrs of symptom development
Key exclusion criteria (13 listed)
- Subject who is contraindicated for endovascular recanalization
- Subject who has hypersensitivity to contrast agent or component of investigational product
- Prohibited or unable to perform MRI test
- Medical history that is related to bleeding
- History of hemorrhagic stroke within 6 months of study participation
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 |
|---|---|---|
| JPI-289 Low-doseJPI-289 Low dose will be intravenously administered during 24 hours | Drug | Low-dose group |
| JPI-289 High-doseJPI-289 High dose will be intravenously administered during 24 hours | Drug | High-dose group |
| PlaceboSame dosage of JPI-289 Low and Hogh dose will be intravenously administered during 24 hours | Drug | Placebo group |
Primary outcome
Infact growth ratio from baseline
Time frame: 4 days from baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2019.
- 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.
Byung Woo Yoon, MD., PhD contact
Yong Woo Lee, MSC contact
15 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 JPI-289 Low-dose and JPI-289 High-dose in people with Acute Ischemic Stroke, run by Jeil Pharmaceutical Co., Ltd. at 15 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 7 inclusion and 13 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 18 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Byung Woo Yoon, MD., PhD (bwyoon@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Infact growth ratio from baseline (time frame: 4 days from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Nov 2019.