Efficacy and Safety Evaluation of 3K3A-APC in Ischemic Stroke
NCT ID: NCT05484154
Last Updated: 2024-10-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2024-10-31
2026-10-31
Brief Summary
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Detailed Description
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The study will be conducted in two phases. During a lead-in dose-finding phase, a maximum of 360 subjects will be randomized to 3K3A-APC or placebo using a Bayesian adaptive approach. Randomized subjects will receive 3K3A-APC or placebo every 12 hours for up to 5 doses (approximately 3 days) or until discharge from the hospital (whichever occurs first). The lead-in phase will transition to one selected 3K3A APC dose-and recruitment will continue-when a single dose proves superior to all other doses and safe.
The definitive phase will continue with the selected dose of 3K3A-APC from the lead-in phase. Randomization will be stratified on 4 variables. Lead-in patients who received the dose selected for the definitive phase will be included in the final data analysis.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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10mg of 3K3A-APC
3K3A-APC, q12h for up to 5 doses
3K3A-APC
3K3A-APC, diluted in 0.9% sodium chloride in water, given at 100 mL IV infusion
15mg of 3K3A-APC
3K3A-APC, q12h for up to 5 doses
3K3A-APC
3K3A-APC, diluted in 0.9% sodium chloride in water, given at 100 mL IV infusion
30mg of 3K3A-APC
3K3A-APC, q12h for up to 5 doses
3K3A-APC
3K3A-APC, diluted in 0.9% sodium chloride in water, given at 100 mL IV infusion
Placebo
Matching placebo, q12h for up to 5 doses
Placebo
Matching placebo, 0.9% sodium chloride in water, given at 100 mL IV infusion
Interventions
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3K3A-APC
3K3A-APC, diluted in 0.9% sodium chloride in water, given at 100 mL IV infusion
Placebo
Matching placebo, 0.9% sodium chloride in water, given at 100 mL IV infusion
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Able to receive thrombolysis, mechanical thrombectomy or both
* National Institutes of Health Stroke Scale (NIHSS) score of ≥ 5
* Signed informed consent
* Agreement to use effective birth control throughout the study
Exclusion Criteria
* History of stroke or penetrating head injury within 90 days prior to enrollment
* History of previous or current diagnosis of intracranial hemorrhage
* Moyamoya disease, cerebral arteriovenous malformation, or known unsecured aneurysm requiring intervention during the acute study period
* Presence of tandem lesions suggesting a likely need for proximal artery stenting during the thrombectomy procedure that would mandate post-operative dual antiplatelet therapy
* Presence of other neurological or non-neurological co-morbidities, independently of the current stroke, that may lead to further deterioration in the subject's neurological status during the study period
* Prolonged prothrombin time (PT) or activated partial thromboplastin time (aPTT)
* Severe hypertension or hypotension
* Blood glucose concentration \< 50 mg/dL
* Prior exposure to any exogenous form of a recombinant variant of human APC
18 Years
90 Years
ALL
No
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
University of Southern California
OTHER
University of Cincinnati
OTHER
University of South Carolina
OTHER
ZZ Biotech, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Patrick D Lyden, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Other Identifiers
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ZZ-3K3A-301
Identifier Type: -
Identifier Source: org_study_id
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