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Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke

Primary Purpose

Acute Ischemic Stroke

Status
Unknown status
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
JPI-289 Low-dose
JPI-289 High-dose
Placebo
Sponsored by
Jeil Pharmaceutical Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Ischemic Stroke

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • Dong-A University HospitalRecruiting
  • Inje University Busan Paik HospitalRecruiting
  • Gyeongsang National University Changwon HospitalRecruiting
  • Yeungnam University Medical CenterRecruiting
  • Chonnam National University HospitalRecruiting
  • Inje University Ilsan Paik HospitalRecruiting
  • Seoul National University Bundang HospitalRecruiting
  • Catholic Kwandong University International St. Mary'S HospitalRecruiting
  • Jeju National University HospitalRecruiting
  • Gyeongsang National University HospitalRecruiting
  • Pusan National University HospitalRecruiting
  • Ewha Womans University Seoul HospitalRecruiting
  • Hanyang University HospitalRecruiting
  • Korea University Guro HospitalRecruiting
  • Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Low-dose group

High-dose group

Placebo group

Arm Description

JPI-289 Low dose or placebo

JPI-289 High dose or placebo

Same dosage of JPI-289 low and high dose

Outcomes

Primary Outcome Measures

Infact growth ratio from baseline

Secondary Outcome Measures

Full Information

First Posted
February 20, 2017
Last Updated
November 14, 2019
Sponsor
Jeil Pharmaceutical Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT03062397
Brief Title
Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 9, 2016 (Actual)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jeil Pharmaceutical Co., Ltd.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Ischemic Stroke

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Sequential Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
110 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low-dose group
Arm Type
Experimental
Arm Description
JPI-289 Low dose or placebo
Arm Title
High-dose group
Arm Type
Experimental
Arm Description
JPI-289 High dose or placebo
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Same dosage of JPI-289 low and high dose
Intervention Type
Drug
Intervention Name(s)
JPI-289 Low-dose
Intervention Description
JPI-289 Low dose will be intravenously administered during 24 hours
Intervention Type
Drug
Intervention Name(s)
JPI-289 High-dose
Intervention Description
JPI-289 High dose will be intravenously administered during 24 hours
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Same dosage of JPI-289 Low and Hogh dose will be intravenously administered during 24 hours
Primary Outcome Measure Information:
Title
Infact growth ratio from baseline
Time Frame
4 days from baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Byung Woo Yoon, MD., PhD
Email
bwyoon@snu.ac.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Yong Woo Lee, MSC
Email
ywlee97@jeilpharm.co.kr
Facility Information:
Facility Name
Dong-A University Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jae Kwan Cha, MD., PhD
Email
nrcjk65@gmail.com
Facility Name
Inje University Busan Paik Hospital
City
Busan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eung-Gyu Kim, MD., PhD
Facility Name
Gyeongsang National University Changwon Hospital
City
Changwon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Seunguk Jung, MD
Facility Name
Yeungnam University Medical Center
City
Daegu
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Lee, MD., PhD
Email
junlee@ynu.ac.kr
Facility Name
Chonnam National University Hospital
City
Gwangju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Man Seok Park, MD., PhD
Email
mspark@chonnam.ac.kr
Facility Name
Inje University Ilsan Paik Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Keun Sik Hong, MD., PhD
Email
nrhks@paik.ac.kr
Facility Name
Seoul National University Bundang Hospital
City
Gyeonggi-do
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moon Ku Han, MD., PhD
Email
mkhan@snu.ac.kr
Facility Name
Catholic Kwandong University International St. Mary'S Hospital
City
Incheon
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Joon An, MD
Facility Name
Jeju National University Hospital
City
Jeju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jay Chol Choi, M.D., PhD
Email
jaychoi@jejunu.ac.kr
Facility Name
Gyeongsang National University Hospital
City
Jinju
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chang Heon Kim, MD.,PhD
Email
honey0407@naver.com
Facility Name
Pusan National University Hospital
City
Pusan
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang Min Sung, MD. PhD
Email
aminoff@hanmail.net
Facility Name
Ewha Womans University Seoul Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tae Jin Song, MD., PhD
Facility Name
Hanyang University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Young Seo Kim, MD. PhD
Email
aescula@daum.net
Facility Name
Korea University Guro Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kyung Mi Oh, MD., PhD
Email
okyungmi@korea.ac.kr
Facility Name
Seoul National University Hospital
City
Seoul
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Byung Woo Yoon, MD., PhD
Email
bwyoon@snu.ac.kr

12. IPD Sharing Statement

Plan to Share IPD
No

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Clinical Trial to Evaluate the Efficacy and Safety of JPI-289 in Patients With Acute Ischemic Stroke

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