Safety Evaluation of 3K3A-APC in Ischemic Stroke

• Status: Completed
• Trial end date: 2017-06-29
• Target enrollment: 0
• Participant gender: All

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 protein C (APC), in in the treatment of acute ischemic stroke following treatment with recombinant tissue plasminogen activator (tPA), mechanical thrombectomy or both.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ZZ Biotech, LLC
• Collaborators: Cedars-Sinai Medical Center; Massachusetts General Hospital; National Institute of Neurological Disorders and Stroke (NINDS); University of Iowa
• Treatments: Protein C

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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