Safety Evaluation of 3K3A-APC in Ischemic Stroke (RHAPSODY)
Purpose of the Study: This study is being completed to determine the safety and tolerability of 3KA-APC, a recombinant variant of human-activated protein C (APC), in combination with tissue plasminogen activator (tPA) in moderately severe acute hemispheric stroke.
Description: This is 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, mechanical thrombectomy or both in subjects with moderate to severe acute ischemic stroke. Approximately 100 subjects will be randomized. This study will utilize a modified version of the continual reassessment method (CRM) to establish a maximum tolerated dose (MTD). Eligible 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. Subjects will be monitored for safety evaluations through day 7 (or discharge, if earlier) and are expected to be seen on day 7, 14, 30 and 90 for safety and outcome evaluations.
Eligibility Criteria: Men and women age 18 to 90 years who have experienced an acute ischemic stroke and are able to receive IV tPA, a mechanical thrombectomy or both. Participants will be excluded if they have a history of stroke or penetrating head injury within 90 days prior to enrollment, or a history of previous or current diagnosis of intracranial hemorrhage. Participants will also be excluded if they have Moyamoya disease, a cerebral arteriovenous malformation (AVM), a known unsecured aneurysm, prolonged prothrombin time, or severe hypertension or hypotension.
Study Status: Open to enrollment
Principal Investigator: Michel Torbey, MD, MPH
Nirav Patel, Clinical Research Coordinator
Funding: ZZ Biotech, LLC