Status:
COMPLETED
Safety Evaluation of 3K3A-APC in Ischemic Stroke
Lead Sponsor:
ZZ Biotech, LLC
Collaborating Sponsors:
National Institute of Neurological Disorders and Stroke (NINDS)
Cedars-Sinai Medical Center
Conditions:
Ischemic Stroke
Eligibility:
All Genders
18-90 years
Phase:
PHASE2
Brief Summary
The purpose of this study was to evaluate the safety, pharmacokinetics (PK) and preliminary efficacy of multiple ascending intravenous doses of 3K3A-APC, a Recombinant Variant of Human activated prote...
Detailed Description
This was a multicenter, prospective, randomized, controlled, double-blinded Phase 2 study intended to evaluate the safety, PK and preliminary efficacy of 3K3A-APC following treatment with tPA, mechani...
Eligibility Criteria
Inclusion
- Acute ischemic stroke
- Able to receive IV tPA, mechanical thrombectomy or both
- National Institutes of Health Stroke Scale (NIHSS) score of ≥ 5
- Signed informed consent
- Mechanical thrombectomy subjects only: onset time to arterial puncture time \< 6 hours
Exclusion
- History of stroke or penetrating head injury within 90 days prior to enrollment
- History of previous or current diagnosis of intracranial hemorrhage that represents a potential for re-hemorrhage if subjected to thrombolytic therapy or mechanical thrombectomy
- Moyamoya disease, cerebral arterio-venous malformation (AVM), known unsecured aneurysm requiring intervention during the acute study period
- Presence of other neurological or non-neurological co-morbidities that may lead, independently of the current stroke, to further deterioration in the subject's neurological status during the trial period
- Presence of premorbid neurological deficits and functional limitations assessed by a retrospective Modified Rankin Scale (mRS) score of ≥ 2
- Mechanical thrombectomy subjects only: baseline non-contrast CT scan revealing a large core occlusion as defined by local protocol
- Prolonged prothrombin time (PT) or activated partial thromboplastin time (aPTT)
- Severe hypertension or hypotension
- Glomerular filtration rate (GFR) \<35 mL/min
- Blood glucose concentration \< 50 mg/dL
- Prior exposure to any exogenous form of APC
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 29 2017
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT02222714
Start Date
October 1 2014
End Date
June 29 2017
Last Update
November 8 2018
Active Locations (15)
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1
Stroke Center
Los Angeles, California, United States, 90048
2
Stroke Center
Chicago, Illinois, United States, 60611
3
Stroke Center
Kansas City, Kansas, United States, 66160
4
Stroke Center
Boston, Massachusetts, United States, 02114